A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Latest Information Update: 12 Dec 2023
At a glance
- Drugs Durvalumab (Primary)
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms PACIFIC
- Sponsors AstraZeneca; AstraZeneca AB; AstraZeneca KK
- 21 Sep 2023 Status changed from active, no longer recruiting to completed.
- 28 Jun 2023 Planned End Date changed from 30 Jun 2023 to 31 Jul 2023.
- 23 Feb 2023 Results of post-hoc subgroup analysis (At data cut-off January 11, 2021) assessing the efficacy and safety analysis from a subgroup of patients with EGFRm non-small cell lung cancer from PACIFIC, published in the Journal of Thoracic Oncology.
Most Recent Events
Trial Overview
Outcome
Purpose
This phase III study is investigating the efficacy of MEDI-4736 following concurrent chemotherapy in patients with non small cell lung cancer.
Comments
According to an AstraZeneca media release, Imfinzi(durvalumab) has been recommended for marketing authorisation in the European Union (EU) for an additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the PACIFIC and CASPIAN trials.
According to an AstraZeneca media release, IMFINZI (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This approval was based on data from several IMFINZI clinical trials, including PACIFIC and CASPIAN trials.
The European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial.
IMFINZI (durvalumab) is approved in the US, Japan, Canada, Switzerland, India and China for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), based on the data from this trial.
In July 2019, the US Food and Drug Administration (FDA) has approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial in an update to the IMFINZI (durvalumab) US Prescribing Information for patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
Primary Endpoints
Overall survival
[ Time Frame: Estimated to be from baseline up to 5 years ]
Overall Survival is defined as the time from the date of randomization until death due to any cause. [1]
Progression Free Survival (PFS)
safety_issue: No
description: Progression-Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
time_frame: Estimated to be from baseline up to 5 years [2]
Other Endpoints
Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
description: ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
time_frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
description: DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.
time_frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1
description: APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.
time_frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1
description: APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.
time_frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1
description: TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.
time_frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Percentage of Patients Alive at 24 Months (OS24)
description: OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.
time_frame: From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Time to Second Progression or Death (PFS2)
description: PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.
time_frame: Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)
description: Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique.
time_frame: At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)
description: The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.
time_frame: At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
description: To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.
time_frame: Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
description: ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.
time_frame: Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO. [3]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Non-small cell lung cancer | treatment | consolidation therapy, stage III |
Subjects
- Subject Type patients
-
Number
Planned: 1000
Actual: 713
- Sex male & female
- Age Group 23-90 (median 64) years; adult; elderly
Patient Inclusion Criteria
1. Age at least 18 years. 2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III) 3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. 4. World Health Organisation (WHO) Performance Status of 0 to 1. 5. Estimated life expectancy of more than 12 weeks.
Patient Exclusion Criteria
1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. 2. Active or prior autoimmune disease or history of immunodeficiency. 3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. 4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. 6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| D4191C00001 | AstraZeneca |
| NCT02125461 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2014-000336-42 | European Clinical Trials Database |
| JapicCTI142733 | Japan Pharmaceutical Information Center - Clinical Trials Information |
| 18180 | United Kingdom Clinical Research Network |
| CANC4122PACIFIC | - |
| 154164 | - |
Organisations
- Sponsors AstraZeneca; AstraZeneca AB; AstraZeneca KK
- Affiliations AstraZeneca; AstraZeneca AB; AstraZeneca KK; MedImmune
Trial Dates
-
Initiation Dates
Planned : 01 May 2014
Actual : 07 May 2014
-
Primary Completion Dates
Planned : 15 May 2017
Actual : 13 Feb 2017
-
End Dates
Planned : 31 Jul 2023
Actual : 24 Aug 2023
Substudies/Extensions
This trial contains a sub-study: Pharmacogenetics Research
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Argentina; Australia; Belgium; Brazil; Canada; Chile; China; Colombia; England; France; Germany; Greece; Hong Kong; Hungary; Israel; Italy; Japan; Malaysia; Mexico; Netherlands; New Zealand; Panama; Peru; Philippines; Poland; Russia; Scotland; Serbia; Singapore; Slovakia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; Ukraine; United Kingdom; USA; Vietnam
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| DurvalumabPrimary Drug | Intravenous | Infusion, Lyophilised |
MEDI4736
MEDI4736 (intravenous infusion)
Drug: MEDI4736 (MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).)
PLACEBO
Placebo (matching placebo for intravenous infusion)
Other: PLACEBO (PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).)
Results
Therapeutic efficacy
Updated 5-year data from the phase III PACIFIC trial, exhibited a durable and sustained overall survival (OS) benefit in patients with unresectable, stage III NSCLC who had not progressed following concurrent chemoradiation therapy (CRT), a previous standard-of-care (SoC) treatment. As of data cut-off (median follow-up duration of 34.2 months in all patients; range, 0.2–74.7 months), updated OS (stratified HR 0.72, 95% CI 0.59–0.89; median 47.5 vs 29.1 months) and PFS (stratified HR 0.55, 95% CI 0.45–0.68; median 16.9 vs 5.6 months) remained consistent with the results from the primary analyses. The 60-month OS rates were 42.9% and 33.4% with durvalumab and placebo, respectively, and 60-month PFS rates were 33.1% and 19.0%, respectively. Updated 4-year data the phase III PACIFIC trial, exhibited a durable and sustained overall survival (OS) benefit in patients with unresectable, stage III NSCLC who had not progressed following concurrent chemoradiation therapy (CRT), a previous standard-of-care (SoC) treatment. Approximately half of patients randomised to durvalumab in the trial were alive at 4 years, and about a third were both alive and progression free, for almost 3 years. The 48-month OS rates were 49.6% for durvalumab compared with 36.3% for placebo, and the rates of PFS rates were 35.3% and 19.5% for durvalumab and placebo, respectively. At afollow up, 34.2 months updated PFS (stratified HR 0.55, 95% CI 0.44–0.67; median 17.2 vs 5.6 months) and OS (stratified HR 0.71, 95% CI 0.57–0.88) was with previous data. Median OS for the durvalumab arm was determined for the first time 47.5 months (pbo, 29.1 months). Updated results from the trial showed durvalumab showed a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit at five years in patients. Long-term data showed 33% of patients remained progression-free at five years. Results from the updated post-hoc analyses showed an estimated five-year OS rate of 42.9% for patients treated with durvalumab versus 33.4% for those on placebo after CRT. Median OS was 47.5 months for durvalumab versus 29.1 for placebo. Following a maximum treatment course of one year, an estimated 33.1% of patients treated with durvalumab had not progressed five years after enrollment versus 19% for placebo. The OS rate was 57 % at three years for patients receiving durvalumab 43.5% for placebo following concurrent CRT. Median OS was not yet reached with the durvalumab when compared to placebo at 29.1 months. After 11.2 months, durvalumab demonstrated a statistically-significant and clinically-meaningful improvement in progression free survival (PFS) (first primary end point), as compared with placebo, in 713 patients with non-small cell lung cancer. PFS improvement was observed across all pre-specified sub-groups, including PD-L1 expression status. The patients who received durvalumab exhibited a lower incidence of metastases, as compared with those receiving placebo. The median PFS values for durvalumab and placebo (standard-of-care) were 16.8 months and 5.6 months, respectively [HR-0.52; 95% CI: 0.42-0.65, p<0.0001]. The duration of response (DoR) was not reached for durvalumab, while the corresponding value for placebo was 13.8 months. The objective response rate (ORR) showed values of 28.4% [95% CI: 24.28-32.89, p < 0.001] and 16% [95% CI: 11.31-21.59, p<0.001], for the drug and placebo, respectively. The trial also met the second primary end point of overall survival (OS) in patients receiving durvalumab compared with placebo by demonstrating 38.4% deaths in treatment arm compared to 48.9% in placebo group. In primary analysis, durvalumab reduced the risk of death by 32% (HR 0.68, [99.73% CI, 0.47-0.997], p = 0.0025).Additionally, durvalumab also showed that PFS was reached by 51.1% patients compared to 73% patients in placebo. After a year of follow up, durvalumab caused a 31% reduction in the risk of death versus placebo after chemoradiation therapy (CRT (HR 0.69, [95% CI, 0.55-0.86] [4] [5] [6] [7] [8] [9] [10] [11] .
Adverse events
In the phase III PACIFIC trial, treatment with durvalumab was generally safe and well tolerated in patients with non-small cell lung cancer (NSCL). Most frequent treatment-related adverse events (AEs) included cough (35.2% versus 25.2%), pneumonitis/radiation pneumonitis (20.2% versus 15.8%), fatigue (24% versus 20.5%), dyspnoea (22.3% versus 23.9%) and diarrhoea (18.3% versus 18.8%) as compared with placebo. Other most frequent adverse reactions reported were rash in 15.4% (n = 73), hypothyroidism in 10.5% (n = 50), diarrhoea 9.7% (n = 46) and interstitial lung disease 9.7% (n = 46) patients, respectively. Grade 3 or 4 AEs was reported in 30.5% versus 26.1% in placebo. In study group 15.4% of patients discontinued treatment due to AEs compared with 9.8% of placebo group, respectively. Treatment led to reduction in risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p = 0.0025). The results were reported from 713 patients recruited in a randomised, double-blind, placebo-controlled study [7] [9] [10] [11] .
Publications
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AstraZeneca. Imfinzi significantly improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-small cell lung cancer. Media-Rel 2018;.
Media Release -
Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares LG, et al. Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial. ASCO-2021 2021; abstr. 8511.
Available from: URL: https://meetinglibrary.asco.org/record/196819/abstract -
AstraZeneca. IMFINZI Demonstrated Unprecedented Survival in Unresectable Stage III Lung Cancer With 43% Of Patients Surviving Five Years. Media-Rel 2021;.
Media Release -
Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, et al. Durvalumab after chemoradiotherapy in stage III NSCLC: 4-year survival update from the phase III PACIFIC trial. ESMO-2020 2020; abstr. LBA49.
Available from: URL: https://www.sciencedirect.com/science/article/pii/S0923753420423634 -
AstraZeneca. Imfinzi demonstrated unprecedented survival in unresectable, Stage III non-small cell lung cancer with an estimated 50% of patients surviving four years . Media-Rel 2020;.
Media Release -
AstraZeneca. Imfinzi is the only immunotherapy to demonstrate overall survival at three years in unresectable Stage III non-small cell lung cancer. Media-Rel 2019;.
Media Release -
AstraZeneca, MedImmune. AstraZeneca Presents Superior Progression-Free Survival for IMFINZI(R) (durvalumab) in the Pacific Trial of Patients with Locally-Advanced Unresectable Lung Cancer at ESMO 2017 Congress. Media-Rel 2017;.
Media Release -
Antonia SJ, Hellmann MD, Dennis PA, Melillo G, Abdullah SE, Lloyd A, et al. A comparative safety analysis for durvalumab in patients with locally advanced, unresectable NSCLC: PACIFIC versus pooled durvalumab monotherapy studies. ASCO-2018 2018; abstr. 8556.
Available from: URL: http://abstracts.asco.org/214/AbstView_214_228461.html -
Han J, Tian K, Yang J, Gong Y. Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis. Lung-Cancer 2020;14642-49.
PubMed | CrossRef Fulltext -
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N-Engl-J-Med 2017;.
PubMed | CrossRef Fulltext -
AstraZeneca. US FDA APPROVES IMFINZI(R) (DURVALUMAB) FOR UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER. Media-Rel 2018;.
Media Release -
Vansteenkiste JF, Naidoo J, Faivre-Finn C, Ozguro?lu M, Villegas A, Daniel D, et al. PACIFIC Subgroup Analysis: Pneumonitis in Stage III, Unresectable NSCLC Patients Treated with Durvalumab vs. Placebo After CRT. WCLC-2018 2018; abstr. MA05.02.
Available from: URL: https://library.iaslc.org/conference-program?product_id=10 -
Garassino MC, Mazieres J, Reck M, Chouaid C, Bischoff H, Reinmuth N, et al. Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial. . J-Thorac-Oncol 2022;.
PubMed | CrossRef Fulltext -
Faivre-Finn C, Spigel D R, Senan S, Langer C J, Raben D, Perez B, et al. Efficacy and safety evaluation based on time from completion of radiotherapy to randomization with durvalumab or placebo in pts from PACIFIC . ESMO-2018 2018; abstr. 1363O.
Available from: URL: http://link.adisinsight.com/Gk97P -
Gray JE, Villegas AE, Daniel DB, Vicente D, Murakami S, Hui R, et al. Three-year overall survival update from the PACIFIC trial. ASCO-2019 2019; abstr. 8526.
Available from: URL: http://abstracts.asco.org/239/AbstView_239_252025.html -
Levra MG, Benet J, Hasan B, Berghmans T, Bruni A, Dingemans AMC, et al. Durvalumab Impact in the Treatment Strategy of Stage III Non-Small Cell Lung Cancer (NSCLC): An EORTC Young Investigator Lung Cancer Group Survey. WCLC-2019 2019; abstr. MA08.02.
Available from: URL: http://link.adisinsight.com/Lf87S -
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N-Engl-J-Med 2018;.
PubMed | CrossRef Fulltext -
Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. . J-Clin-Oncol 2022;JCO2101308 .
PubMed | CrossRef Fulltext -
Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, et al. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung-Cancer 2022;16684-93.
PubMed | CrossRef Fulltext -
Naidoo J, Antonia S, Wu YL, Cho BC, Thiyagarajah P, Mann H, et al. Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-mutant NSCLC: A Post-Hoc Subgroup Analysis from PACIFIC. J-Thorac-Oncol 2023;.
PubMed | CrossRef Fulltext -
Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, et al. Brief report: Three-year overall survival with durvalumab after chemoradiotherapy in Stage III NSCLC - Update from PACIFIC. J-Thorac-Oncol 2019;.
PubMed | CrossRef Fulltext -
Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, et al. Patient-reported outcomes (PROs) with durvalumab by PD-L1 expression in unresectable, stage III NSCLC (PACIFIC). Ann-Oncol 2019;30 (Suppl. 2)ii78.
PubMed | CrossRef Fulltext -
Spira A, Planchard D, Cho BC, Ozguro?lu M, Daniel D, Villegas A, et al. Expanded Efficacy and Safety Analysis of PACIFIC Based on a PD-L1 Cutpoint of 25%. WCLC-2018 2018; abstr. P1.16-06.
Available from: URL: https://library.iaslc.org/conference-program?product_id=10 -
AstraZeneca. AstraZeneca to Present Transformative Data at ESMO Asia 2017 Congress from Pivotal Trials Showing Potential New Standards of Care in Non-small Cell Lung Cancer. Media-Rel 2017;.
Media Release -
Tetafort A, Haug H, Le Pechoux C, Chouaid C, Gherardi A, Caillon M, et al. Cost-Effectiveness Analysis of Durvalumab in Adult Patients with Locally Advanced Unresectable Non-Small Cell Lung Cancer after Concurrent Platinum-Based Chemoradiation in France. EISPOR-2019 2019; abstr. PCN145.
Available from: URL: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2019-3119/98251 -
Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguro?lu M, Murakami S, Hui R, et al. Non-pneumonitis immune-mediated adverse events (imAEs) with durvalumab in patients with unresectable stage III NSCLC (PACIFIC). ASCO-2020 2020; abstr. 9048.
Available from: URL: https://meetinglibrary.asco.org/record/187055/abstract -
Naidoo J, Antonia SJ, Wu Y-L, Cho BC, Thiyagarajah P, Mann H, et al. Durvalumab (durva) after chemoradiotherapy (CRT) in unresectable, stage III, EGFR mutation-positive (EGFRm) NSCLC:A post hoc subgroup analysis from PACIFIC. ASCO-2022 2022; abstr. 8541.
Available from: URL: https://meetings.asco.org//abstracts-presentations/207568 -
Mooradian MJ, Taylor S, Ramsden R, van Keep M, Dunlop W, Brannman L, et al. Cost-Effectiveness of Durvalumab Following Chemoradiotherapy in Unresectable Stage III NSCLC Patients in the US: An Update Based on 5-Year Pacific Data. EISPOR-2021 2021; abstr. POSC110.
Available from: URL: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2021-3409/112796 -
Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, et al. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, Stage III non-small-cell lung cancer in the PACIFIC trial. Ann-Oncol 2020;.
PubMed | CrossRef Fulltext -
Planchard D, Ozguro?lu M, Daniel D, Villegas A, Vicente D, Murakami S, et al. Impact of smoking on outcomes with durvalumab following chemoradiotherapy in unresectable Stage III NSCLC (PACIFIC). AACR-I-2020 2020; abstr. CT213.
Available from: URL: http://link.adisinsight.com/Sg72Y -
Ashraf SMM, Pandita S, Alimpertis E, Khan T, Verghese C. Progression free survival (PFS) benefits of immuno-oncology agents (IOs) and implications for market cost-sharing inefficiencies. ASCO-2019 2019; abstr. 6643.
Available from: URL: http://abstracts.asco.org/239/AbstView_239_268509.html -
Vansteenkiste JF, Naidoo J, Faivre-Finn C, Ozguro?lu M, Villegas A, Daniel D, et al. Efficacy of durvalumab in patients with stage III NSCLC who experience pneumonitis (PACIFIC). ESMO-2019 2019; abstr. 1459PD.
Available from: URL: https://academic.oup.com/annonc/article/30/Supplement_5/mdz259.002/5577228 -
Hui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, et al. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet-Oncol 2019;.
PubMed | CrossRef Fulltext -
Planchard D, Garassino MC, Paz-Ares L, Faivre-Finn C, Spira A, Gu Y, et al. Prevalence of programmed death ligand-1 (PD-L1) by demographic, disease and sample characteristics in unresectable, stage III NSCLC (PACIFIC). Ann-Oncol 2019;30 (Suppl. 2)ii32-ii33.
PubMed | CrossRef Fulltext -
Planchard D, Cho BC, Gray JE, Paz-Ares LG, Ozguroglu M, Villegas AE, et al. First subsequent treatment after discontinuation of durvalumab in unresectable, stage III NSCLC patients from PACIFIC. ASCO-2019 2019; abstr. 9054.
Available from: URL: http://abstracts.asco.org/239/AbstView_239_257453.html -
Spigel DR, Vansteenkiste JF, Reck M, Wakelee HA, Ozguro?lu M, Daniel D, et al. Effect of Induction Chemotherapy in the PACIFIC Study. WCLC-2018 2018; abstr. P1.16-05.
Available from: URL: https://library.iaslc.org/conference-program?product_id=10 -
Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, et al. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung-Cancer 2021;15130-38.
PubMed | CrossRef Fulltext -
Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, et al. Brief report: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial. . J-Thorac-Oncol 2021;.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Giovanni Melillo, MD | AstraZeneca |
-
|
|
Information Centre
Södertälje
show details
Södertälje Postcode: SE 151 85 Sweden information.centre@astrazeneca.com |
AstraZeneca AB | Sweden |
|
Marc Ballas
Phone: 800-236-9933
show details
ClinicalTrialTransparency@astrazeneca.com |
AstraZeneca |
-
|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - | Aalst | Belgium |
| - | Adana | Turkey |
| - | Alicante | Spain |
| - | Amsterdam | Netherlands |
| - | Anaheim, California | USA |
| - | Angers | France |
| - | Ankara | Turkey |
| - | Arequipa | Peru |
| - | Athens | Greece |
| - | Atlanta, Georgia | USA |
| - | Augusta, Georgia | USA |
| - | Austin, Texas | USA |
| - | Aviano | Italy |
| - | Avignon Cedex 9 | France |
| - | Bahia Blanca | Argentina |
| - | Baltimore, Maryland | USA |
| - | Bangkok | Thailand |
| - | Barcelona | Spain |
| - | Bardejov | Slovakia |
| - | Barretos | Brazil |
| - | Barrie, Ontario | Canada |
| - | Bayonne | France |
| - | Bedford Park | Australia |
| - | Belo Horizonte | Brazil |
| - | Bendigo | Australia |
| - | Benevento | Italy |
| - | Berazategui | Argentina |
| - | Berlin | Germany |
| - | Bloemfontein | South-Africa |
| - | Boston, Massachusetts | USA |
| - | Box Hill | Australia |
| - | Brasília | Brazil |
| - | Bratislava | Slovakia |
| - | Breda | Netherlands |
| - | Brest Cedex | France |
| - | Bronx, New York | USA |
| - | Budapest | Hungary |
| - | Buenos Aires | Argentina |
| - | Bunkyo-ku | Japan |
| - | Burlington, North Carolina | USA |
| - | Busan | South-Korea |
| - | Córdoba | Argentina |
| - | Cachoeiro de Itapemirim | Brazil |
| - | Cagayan de Oro City | Philippines |
| - | Calgary, Alberta | Canada |
| - | Canton, Ohio | USA |
| - | Cape Town | South-Africa |
| - | Catania | Italy |
| - | Cebu City | Philippines |
| - | Chandler, Arizona | USA |
| - | Charlotte, North Carolina | USA |
| - | Cheongju-si | South-Korea |
| - | Chuo-ku | Japan |
| - | Cincinnati, Ohio | USA |
| - | Ciudad Autonoma Buenos Aires | Argentina |
| - | Clayton | Australia |
| - | Cordoba | Argentina |
| - | Coswig | Germany |
| - | Coventry | United-Kingdom |
| - | Cremona | Italy |
| - | Crete | Greece |
| - | Creteil | France |
| - | Cuautitlan Izcalli | Mexico |
| - | Cusco | Peru |
| - | Dallas, Texas | USA |
| - | Decatur, Illinois | USA |
| - | Denver, Colorado | USA |
| - | Dijon | France |
| - | Durban | South-Africa |
| - | Edmonton, Alberta | Canada |
| - | Eindhoven | Netherlands |
| - | El Salto | Mexico |
| - | Esslingen a. N. | Germany |
| - | Evanston, Illinois | USA |
| - | Fairfax, Virginia | USA |
| - | Fayetteville, Arkansas | USA |
| - | Fleming Island, Florida | USA |
| - | Fort Myers, Florida | USA |
| - | Fort Worth, Texas | USA |
| - | Fortaleza | Brazil |
| - | Fukuoka | Japan |
| - | Fullerton, California | USA |
| - | Gdańsk | Poland |
| - | Gent | Belgium |
| - | Gerona | Spain |
| - | Gilly | Belgium |
| - | Glasgow | United-Kingdom |
| - | Goch | Germany |
| - | Goodyear, Arizona | USA |
| - | Greenfield Park, Quebec | Canada |
| - | Greensville, South Carolina | USA |
| - | Grosshansdorf | Germany |
| - | Guadalajara | Mexico |
| - | Gyula | Hungary |
| - | Habikino-shi | Japan |
| - | Hackensack, New Jersey | USA |
| - | Haifa | Israel |
| - | Hamburg | Germany |
| - | Hanoi | Vietnam |
| - | Hazard, Kentucky | USA |
| - | Heidelberg | Australia |
| - | Herston | Australia |
| - | Hidaka-shi | Japan |
| - | Hirakata-shi | Japan |
| - | Hiroshima-shi | Japan |
| - | Ho Chi Minh | Vietnam |
| - | Houston, Texas | USA |
| - | Hue | Vietnam |
| - | Hwasun-gun | South-Korea |
| - | Ijuí | Brazil |
| - | Incheon | South-Korea |
| - | Istanbul | Turkey |
| - | Itajai | Brazil |
| - | Izmir | Turkey |
| - | Jerusalem | Israel |
| - | Johannesburg | South-Africa |
| - | Jonesboro, Arkansas | USA |
| - | Juiz de Fora | Brazil |
| - | Kanazawa | Japan |
| - | Kashiwa-shi | Japan |
| - | Kfar Saba | Israel |
| - | Kitaadachi-gun | Japan |
| - | Kogarah | Australia |
| - | Konya | Turkey |
| - | Kosice | Slovakia |
| - | Kurume-shi | Japan |
| - | Löwenstein | Germany |
| - | La Mesa, California | USA |
| - | La Plata | Argentina |
| - | La Rioja | Argentina |
| - | Lake Success, New York | USA |
| - | Lansing, Michigan | USA |
| - | Larissa | Greece |
| - | Launceston | Australia |
| - | Lawrenceville, Georgia | USA |
| - | Lecce | Italy |
| - | Leuven | Belgium |
| - | Liège | Belgium |
| - | Libramont-Chevigny | Belgium |
| - | Lille | France |
| - | Lima | Peru |
| - | Lincoln, Nebraska | USA |
| - | Lleida | Spain |
| - | London | United-Kingdom |
| - | London, Ontario | Canada |
| - | Los Angeles, California | USA |
| - | Lubeck | Germany |
| - | Lublin | Poland |
| - | Lucca | Italy |
| - | LYON Cedex 08 | France |
| - | Maastricht | Netherlands |
| - | Madrid | Spain |
| - | Malatya | Turkey |
| - | Manchester | United-Kingdom |
| - | Manila | Philippines |
| - | Marietta, Georgia | USA |
| - | Marseille Cedex 20 | France |
| - | Matsuyama-shi | Japan |
| - | Mexico | Mexico |
| - | Miami Beach, Florida | USA |
| - | Middleton, Ohio | USA |
| - | Milano | Italy |
| - | Miskolc | Hungary |
| - | Monterrey | Mexico |
| - | Montpellier Cedex | France |
| - | Morristown, New Jersey | USA |
| - | Muang | Thailand |
| - | Nagoya-shi | Japan |
| - | Nantes | France |
| - | Napoli | Italy |
| - | Nashville, Tennessee | USA |
| - | Natori-shi | Japan |
| - | Nedlands | Australia |
| - | New York, New York | USA |
| - | Newmarket, Ontario | Canada |
| - | Nice | France |
| - | Norwich, Connecticut | USA |
| - | Nove Zamky | Slovakia |
| - | Oaxaca | Mexico |
| - | Obninsk | Russia |
| - | Ocala, Florida | USA |
| - | Okayama-shi | Japan |
| - | Orange, California | USA |
| - | Orizaba | Mexico |
| - | Orlando, Florida | USA |
| - | Osaka-shi | Japan |
| - | Osakasayama-shi | Japan |
| - | Oshawa, Ontario | Canada |
| - | Ota-shi | Japan |
| - | Oxnard, California | USA |
| - | Passo Fundo | Brazil |
| - | Patra | Greece |
| - | Pau Cedex | France |
| - | Pergamino | Argentina |
| - | Petah Tikva | Israel |
| - | Philadelphia, Pennsylvania | USA |
| - | Pilar | Argentina |
| - | Pinehurst, North Carolina | USA |
| - | Pisa | Italy |
| - | Pittsburgh, Pennsylvania | USA |
| - | Port Macquarie | Australia |
| - | Port St Lucie, Florida | USA |
| - | Porto Alegre | Brazil |
| - | Poznan | Poland |
| - | Pretoria | South-Africa |
| - | Randwick | Australia |
| - | Recklinghausen | Germany |
| - | Regensburg | Germany |
| - | Regina, Saskatchewan | Canada |
| - | Rehovot | Israel |
| - | Rennes | France |
| - | Rio de Janeiro | Brazil |
| - | Rockville, Maryland | USA |
| - | Roma | Italy |
| - | Rosario | Argentina |
| - | Rotterdam | Netherlands |
| - | São José do Rio Preto | Brazil |
| - | São Paulo | Brazil |
| - | Sacramento, California | USA |
| - | Sagamihara-shi | Japan |
| - | Saint Herblain | France |
| - | Saint Louis Park, Minnesota | USA |
| - | Sakai-shi | Japan |
| - | Salem, Virginia | USA |
| - | Salisbury, Maryland | USA |
| - | Salt Lake City, Utah | USA |
| - | San Sebastian | Spain |
| - | Santa Cruz do Sul | Brazil |
| - | Santa Rosa, California | USA |
| - | SAntiago | Chile |
| - | Santo André | Brazil |
| - | Sapporo-shi | Japan |
| - | Seattle, Washington | USA |
| - | Sendai-shi | Japan |
| - | Seongnam-si | South-Korea |
| - | Seoul | South-Korea |
| - | Sevilla | Spain |
| - | Shinjuku-ku | Japan |
| - | Singapore | Singapore |
| - | Songkla | Thailand |
| - | Spokane, Washington | USA |
| - | St Louis, Missouri | USA |
| - | St. Petersburg | Russia |
| - | St. Petersburg, Florida | USA |
| - | Sunto-gun | Japan |
| - | Suwon | South-Korea |
| - | Taichung | Taiwan |
| - | Taipei | Taiwan |
| - | Takatsuki-shi | Japan |
| - | Tampa, Florida | USA |
| - | Tel Aviv | Israel |
| - | Tel Hashomer | Israel |
| - | Temuco | Chile |
| - | Thessaloniki | Greece |
| - | Tilburg | Netherlands |
| - | Topeka, Kansas | USA |
| - | Toronto, Ontario | Canada |
| - | Toulouse | France |
| - | Towson, Maryland | USA |
| - | Trier | Germany |
| - | Trnava | Slovakia |
| - | Truro | United-Kingdom |
| - | Tyler, Texas | USA |
| - | Ube-shi | Japan |
| - | Valencia | Spain |
| - | Vancouver, British Columbia | Canada |
| - | Vancouver, Washington | USA |
| - | Vereeniging | South-Africa |
| - | Viña del Mar | Chile |
| - | Viedma | Argentina |
| - | Villejuif Cedex | France |
| - | Villingen-Schwenningen | Germany |
| - | Vina del Mar | Chile |
| - | Würzburg | Germany |
| - | Warszawa | Poland |
| - | Waterloo, Iowa | USA |
| - | Westmead | Australia |
| - | Winston-Salem, North Carolina | USA |
| - | Wolverhampton | United-Kingdom |
| - | Woolloongabba | Australia |
| - | Worms | Germany |
| - | Yokohama-shi | Japan |
| - | Yvoir | Belgium |
| - | Zaragoza | Spain |
| - | Zerifin | Israel |
| AstraZeneca |
-
|
-
|
| AstraZeneca AB | Sodertalje | Sweden |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 12 Dec 2023 | Other trial event | Last checked against the European Clinical Trials Database record. Updated 12 Dec 2023 |
| 12 Oct 2023 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 12 Oct 2023 |
| 21 Sep 2023 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 12 Oct 2023 |
| 28 Jun 2023 | Completion date | Planned End Date changed from 30 Jun 2023 to 31 Jul 2023. Updated 05 Jul 2023 |
| 23 Feb 2023 | Results | Results of post-hoc subgroup analysis (At data cut-off January 11, 2021) assessing the efficacy and safety analysis from a subgroup of patients with EGFRm non-small cell lung cancer from PACIFIC, published in the Journal of Thoracic Oncology. Updated 01 Mar 2023 |
| 04 Jan 2023 | Completion date | Planned End Date changed from 30 Dec 2022 to 30 Jun 2023. Updated 03 Feb 2023 |
| 09 Aug 2022 | Results | Results (n=117) assessing safety and tolerability of durvalumab following sequential chemoradiotherapy, published in the Journal of Thoracic Oncology. Updated 22 Aug 2022 |
| 07 Jun 2022 | Results | Results(n=35 ) of post hoc exploratory analysis evaluating efficacy and safety in patients with EGFRm NSCLC, presented at the 58th Annual Meeting of the American Society of Clinical Oncology Updated 15 Jul 2022 |
| 15 May 2022 | Other trial event | This trial has been completed in Belgium, according to European Clinical Trials Database record. Updated 20 May 2022 |
| 01 Apr 2022 | Results | Results of post-hoc analysis assessing the occurrence of imAEs (pneumonitis and non-pneumonitis) in PACIFIC in terms of: incidence, severity, and timing; clinical management and outcomes; and associations between the occurrence of imAEs and (1) all-cause AEs and (2) baseline patient, disease, and treatment characteristics, published in the Lung Cancer. Updated 09 May 2022 |
| 02 Feb 2022 | Results | Results of exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned published in the Journal of Clinical Oncology Updated 11 Feb 2022 |
| 17 Jan 2022 | Completion date | Planned End Date changed from 31 Dec 2021 to 30 Dec 2022. Updated 27 Jan 2022 |
| 03 Dec 2021 | Results | Results assessing the cost-effectiveness of durvalumab following chemoradiotherapy (CRT) versus CRT alone for unresectable stage III NSCLC using 5-year follow-up data from the PACIFIC trial, presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research Updated 11 Jan 2022 |
| 05 Aug 2021 | Other trial event | According to an AstraZeneca company website, the company has full acquired Medimmune on 14 Feb 2019. Updated 26 Apr 2022 |
| 28 Jul 2021 | Other trial event | This trial has been completed in Greece, according to European Clinical Trials Database record. Updated 28 Jul 2021 |
| 08 Jun 2021 | Results | Results of an updated, exploratory analysis assessing OS and PFS based on 5-year data presented at the 57th Annual Meeting of the American Society of Clinical Oncology Updated 31 Jul 2021 |
| 04 Jun 2021 | Other trial event | According to an AstraZeneca media release, David Spigel is the investigator for this trial. Updated 10 Jun 2021 |
| 04 Jun 2021 | Results | According to an AstraZeneca media release, results from this trial were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated 10 Jun 2021 |
| 04 Jun 2021 | Results | Results from the updated post-hoc analyses published in an AstraZeneca Media Release. Updated 10 Jun 2021 |
| 19 May 2021 | Other trial event | According to an AstraZeneca media release, data from this study will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated 24 May 2021 |
| 16 May 2021 | Other trial event | This trial has been completed in Poland, according to European Clinical Trials Database. Updated 17 May 2021 |
| 11 May 2021 | Completion date | Planned End Date changed from 31 Mar 2021 to 31 Dec 2021. Updated 04 Jun 2021 |
| 03 Apr 2021 | Other trial event | This trial has been completed in Slovakia, according to European Clinical Trials Database record. Updated 05 Apr 2021 |
| 05 Feb 2021 | Other trial event | This trial has been completed in Germany, according to European Clinical Trials Database record. (Global end date:2021-01-18) Updated 05 Feb 2021 |
| 18 Jan 2021 | Results | Results of an exploratory analysis assessing overall survival and progression free survival published in the Journal of Thoracic Oncology Updated 01 Feb 2021 |
| 01 Jan 2021 | Protocol amendment | Adult patients if they had WHO performance status 0 or 1 and stable or responding disease following at least two cycles of platinum-based combination CT concurrent with curative-intent RT, which must have been completed within 1-14 days before randomization (which became 1-42 days after a protocol amendment). Updated 09 Jun 2021 |
| 01 Jan 2021 | Results | Results of a post-hoc, exploratory analysis published in the Lung Cancer Updated 09 Jun 2021 |
| 15 Dec 2020 | Other trial event | According to an AstraZeneca media release, Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the PACIFIC and CASPIAN trials. Updated 22 Dec 2020 |
| 15 Dec 2020 | Other trial event | According to an AstraZeneca media release, Imfinzi(durvalumab) has been recommended for marketing authorisation in the European Union (EU) for an additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Updated 22 Dec 2020 |
| 20 Nov 2020 | Other trial event | According to an AstraZeneca media release, IMFINZI (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This approval was based on data from several IMFINZI clinical trials, including PACIFIC and CASPIAN trials. Updated 04 Dec 2020 |
| 21 Sep 2020 | Results | Four years updated survival results from exploratory analyses presented at the 45th European Society for Medical Oncology Congress Updated 14 Oct 2020 |
| 18 Sep 2020 | Other trial event | According to an AstraZeneca media release, Corinne Faivre-Finn is the lead investigator of this study. Updated 22 Sep 2020 |
| 18 Sep 2020 | Results | According to an AstraZeneca media release, data from this study were published The New England Journal of Medicine. Updated 22 Sep 2020 |
| 18 Sep 2020 | Results | According to an AstraZeneca media release, data from this study were presented at the ESMO Virtual Congress 2020. Updated 22 Sep 2020 |
| 18 Sep 2020 | Results | Results published in the AstraZeneca media release Updated 22 Sep 2020 |
| 08 Sep 2020 | Other trial event | According to an AstraZeneca media release, data from this study will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Updated 08 Sep 2020 |
| 01 Aug 2020 | Results | Results of a cost-effective analysis published in the Lung Cancer Updated 20 Jul 2021 |
| 18 Jun 2020 | Other trial event | Planned number of patients changed from 880 to 1000. Updated 18 Jun 2020 |
| 31 May 2020 | Results | Results of exploratory analyses evaluating non-pneumonitis immune-mediated adverse events patients with NSCLC treated with durvalumab, presented at the 56th Annual Meeting of the American Society of Clinical Oncology Updated 20 Jun 2020 |
| 28 Apr 2020 | Results | Results from exploratory post hoc analysis assessing impact of smoking on trial outcomes presented at the 111th Annual Meeting of the American Association for Cancer Research - I Updated 12 May 2020 |
| 12 Mar 2020 | Results | Results published in the Annals of Oncology Updated 31 Mar 2020 |
| 12 Dec 2019 | Other trial event | According to an AstraZeneca media release, China's National Medical Products Administration (NMPA) has approved Imfinzi (durvalumab) for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), based on the results from this trial. Updated 17 Dec 2019 |
| 06 Nov 2019 | Results | Results presented at the 22nd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research Updated 11 Nov 2019 |
| 14 Oct 2019 | Results | Results of post hoc exploratory analysis reporting updated OS outcomes from PACIFIC published in the Journal of Thoracic Oncology Updated 30 Oct 2019 |
| 07 Oct 2019 | Results | Results of post-hoc analysis published in the Lancet Oncology. Updated 18 Oct 2019 |
| 01 Oct 2019 | Results | Results (Data cutoff: 22 March 2018) of efficacy of durvalumab in patients with stage III NSCLC who experience pneumonitis has been presented at the 44th European Society for Medical Oncology Congress Updated 15 Feb 2020 |
| 16 Sep 2019 | Completion date | Planned End Date changed from 9 Jul 2019 to 31 Mar 2021. Updated 26 Sep 2019 |
| 16 Sep 2019 | Other trial event | According to an AstraZeneca media release, results from this study will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, 27 September to 1 October 2019. Updated 18 Sep 2019 |
| 10 Sep 2019 | Results | Results presented at the 20th World Conference on Lung Cancer. Updated 17 Oct 2019 |
| 22 Jul 2019 | Other trial event | According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial in an update to the IMFINZI (durvalumab) US Prescribing Information for patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). Updated 23 Jul 2019 |
| 04 Jun 2019 | Results | Results presented at the 55th Annual Meeting of the American Society of Clinical Oncology Updated 15 Jun 2019 |
| 04 Jun 2019 | Results | Results assessing 3-year overall survival of MEDI4736 in patients with non-small cell lung cancer, presented at the 55th Annual Meeting of the American Society of Clinical Oncology. Updated 11 Jun 2019 |
| 04 Jun 2019 | Results | Results assessing PFS benefits of immuno-oncology agents and implications for market cost-sharing inefficiencies using data from phase 3 trials, presented at the 55th Annual Meeting of the American Society of Clinical Oncology Updated 07 Jun 2019 |
| 02 Jun 2019 | Results | Results presented in an AstraZeneca Media Release. Updated 04 Jun 2019 |
| 02 Jun 2019 | Results | According to an AstraZeneca Media Release, data from this study were presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2019. Updated 04 Jun 2019 |
| 16 May 2019 | Other trial event | According to an AstraZeneca Media Release, data from this trial will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2019 in Chicago, May 31-June 4. Updated 23 May 2019 |
| 01 Apr 2019 | Results | Results of exploratory analyses of the prevalence of tumour PD-L1 expression were published in the Annals of Oncology Updated 12 Mar 2020 |
| 01 Apr 2019 | Results | Results assessing patient reported outcomes of Durvalumab published in the Annals of Oncology Updated 12 Mar 2020 |
| 24 Oct 2018 | Other trial event | Last checked against Japan Pharmaceutical Information Center. Updated 24 Oct 2018 |
| 23 Oct 2018 | Results | Results evaluating safety and efficacy of Durvalumab presented at the 43rd European Society for Medical Oncology Congress Updated 08 Jan 2019 |
| 09 Oct 2018 | Other trial event | According to an AstraZeneca media release, data will be presented at the ESMO 2018 Congress. Updated 16 Oct 2018 |
| 26 Sep 2018 | Results | Results presented at the 19th World Conference on Lung Cancer Updated 09 Oct 2018 |
| 26 Sep 2018 | Results | Results presented at the 19th World Conference on Lung Cancer Updated 09 Oct 2018 |
| 26 Sep 2018 | Results | Results of exploratory subgroup analysis of PACIFIC trial (n=709, data cut off: 12 Feb 2017) presented at the 19th World Conference on Lung Cancer Updated 09 Oct 2018 |
| 25 Sep 2018 | Results | Results published in the New England Journal of Medicine Updated 11 Oct 2018 |
| 24 Sep 2018 | Other trial event | According to an AstraZeneca media release, the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on greater than or equal to 1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial. Updated 28 Sep 2018 |
| 27 Jul 2018 | Other trial event | According to an AstraZeneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on greater than or equal to 1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). Updated 03 Aug 2018 |
| 02 Jul 2018 | Other trial event | According to an AstraZeneca media release, full results will be presented at a forthcoming medical meeting. Updated 10 Jul 2018 |
| 02 Jul 2018 | Other trial event | According to an AstraZeneca media release, Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), based on the data from this trial. Imfinzi is also approved Switzerland and India based on this trial. EU decision expected in the second half of 2018. Updated 10 Jul 2018 |
| 05 Jun 2018 | Results | Results of a comparative safety analysis of PACIFIC trial and a pooled dataset of three trials [PACIFIC (n=475), ATLANTIC (n=444 advanced NSCLC pts), and a Phase I/II 1108 (n=970 solid tumor pts, including 304 NSCLC pts)] presented at the 54th Annual Meeting of the American Society of Clinical Oncology. Updated 15 Jun 2018 |
| 25 May 2018 | Other trial event | According to an Astrazeneca media release, the company plans to present results from the PACIFIC trial at a forthcoming medical meeting and sharing these results with Health Authorities to support ongoing regulatory interactions. Updated 31 May 2018 |
| 25 May 2018 | Endpoint met | Primary endpoint of Overall survival has been met, according to an AstraZeneca Media Release. Updated 31 May 2018 |
| 25 May 2018 | Interim results | Interim analysis results presented in an AstraZeneca Media Release. Updated 31 May 2018 |
| 09 May 2018 | Other trial event | According to an Astrazeneca media release, based on the data from this trial, the Health Canada bas approved IMFINZI (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), Updated 17 May 2018 |
| 03 Apr 2018 | Other trial event | According to an AstraZeneca media release, data from this trial will be presented the European Lung Cancer Conference (ELCC) in Geneva,11-14 April, and the American Association for Cancer Research (AACR) annual meeting in Chicago,14-18 April Updated 09 Apr 2018 |
| 19 Feb 2018 | Other trial event | According to an Astrazeneca media release, Scott J. Antonia is investigator in the PACIFIC trial. Updated 22 Feb 2018 |
| 16 Feb 2018 | Other trial event | According to an Astrazeneca media release, US Food and Drug Administration (FDA) has approved IMFINZI (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), based on the data from this trial. Updated 20 Feb 2018 |
| 16 Feb 2018 | Results | Results published in the AstraZeneca media release. Updated 20 Feb 2018 |
| 16 Nov 2017 | Results | Results published in the AstraZeneca media release. Updated 23 Nov 2017 |
| 16 Nov 2017 | Other trial event | According to an Astrazeneca media release, results of a planned interim analysis from this trial will be presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress. Updated 23 Nov 2017 |
| 17 Oct 2017 | Other trial event | According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for IMFINZI (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted IMFINZI Priority Review status. Updated 19 Oct 2017 |
| 09 Oct 2017 | Other trial event | According to an AstraZeneca media release, Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) to European Medicines Agency (EMA) is based on positive progression-free survival (PFS) data from thsi trial. Updated 26 Oct 2017 |
| 08 Sep 2017 | Interim results | According to an AstraZeneca media release, data was presented at the European Society of Medical Oncology (ESMO) 2017 Congress. Updated 12 Sep 2017 |
| 08 Sep 2017 | Interim results | Results published in an AstraZeneca media release. Updated 12 Sep 2017 |
| 08 Sep 2017 | Interim results | Results of an interim analysis (As of February 13, 2017) published in the New England Journal of Medicine Updated 12 Sep 2017 |
| 31 Jul 2017 | Other trial event | According to a MedImmune media release, basis on the interim results of this study the US FDA has granted Breakthrough Therapy Designation for IMFINZI (durvalumab), for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. Updated 02 Aug 2017 |
| 26 May 2017 | Other trial event | According to an AstraZeneca media release, data from this study will be presented at American Society of Clinical Oncology (ASCO) Annual Meeting 2017. Updated 31 May 2017 |
| 12 May 2017 | Other trial event | Independent Data Monitoring Committee (IDMC) conducted a planned interim analysis and concluded that the trial has already met a primary endpoint, according to a AstraZeneca media release. Updated 19 May 2017 |
| 12 May 2017 | Other trial event | According to a AstraZeneca media release, the company plans to submit the initial results for presentation at a forthcoming medical meeting. Updated 19 May 2017 |
| 12 May 2017 | Endpoint met | Primary endpoint of progression-free survival has been met, according to a AstraZeneca media release. Updated 19 May 2017 |
| 11 May 2017 | Other trial event | Planned primary completion date changed from 31 Jan 2017 to 15 May 2017. Updated 15 May 2017 |
| 01 May 2017 | Other trial event | Planned primary completion date changed from 1 May 2017 to 31 Jan 2017. Updated 07 May 2017 |
| 01 Sep 2016 | Completion date | Planned End Date changed from 1 Jan 2020 to 1 Jul 2019. Updated 16 Sep 2016 |
| 30 Jun 2016 | Other trial event | Last checked against United Kingdom Clinical research Network record. Updated 30 Jun 2016 |
| 24 May 2016 | Other trial event | New source identified and integrated (Japan Pharmaceutical Information Center - Clinical Trials Information; JapicCTI142733) Updated 24 May 2016 |
| 07 Apr 2016 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov. Updated 11 Apr 2016 |
| 24 Feb 2016 | Other trial event | New source identified and integrated (United Kingdom Clinical Research Network 18180). Updated 24 Feb 2016 |
| 04 Feb 2016 | Other trial event | According to an AstraZeneca media release, regulatory submissions for durvalumab for the treatment of stage III non-small cell lung cancer (NSCLC) are anticipated in 2017 in the USA and in 2020 in EU and Japan. Updated 15 Feb 2016 |
| 04 Feb 2016 | Other trial event | According to an AstraZeneca media release, more than 50% of planned patients have been randomized. Updated 11 Feb 2016 |
| 29 May 2015 | Other trial event | Planned primary completion date changed from 1 Aug 2016 to 1 May 2017 according to ClinicalTrials.gov record. Updated 11 Jun 2015 |
| 21 Oct 2014 | Other trial event | New source identified and integrated (European Clinical Trials Database; EudraCT2014-000336-42). Updated 21 Oct 2014 |
| 15 Sep 2014 | Completion date | According to the ClinicalTrials.gov record, planned end date changed from 1 Nov 2020 to 1 Jan 2020. Updated 17 Oct 2014 |
| 19 Aug 2014 | Other trial event | According to the ClinicalTrials.gov record, planned number of patients changed from 880 to 702. Updated 17 Oct 2014 |
| 20 May 2014 | Completion date | Planned End Date changed from 1 Jul 2019 to 1 Nov 2020 as reported by ClinicalTrials.gov. Updated 04 Jul 2014 |
| 20 May 2014 | Other trial event | Planned primary completion date changed to 1 May 2017 as reported by ClinicalTrials.gov. Updated 04 Jul 2014 |
| 20 May 2014 | Status change - recruiting | Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov. Updated 04 Jul 2014 |
| 02 May 2014 | New trial record | New trial record Updated 02 May 2014 |
Table of Contents
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