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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)

Trial Profile

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2019

At a glance

  • Drugs Durvalumab (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PACIFIC
  • Sponsors AstraZeneca
  • Most Recent Events

    • 09 Oct 2018 According to an AstraZeneca media release, data will be presented at the ESMO 2018 Congress.
    • 26 Sep 2018 Results presented at the 19th World Conference on Lung Cancer
    • 26 Sep 2018 Results presented at the 19th World Conference on Lung Cancer

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

This phase III study is investigating the efficacy of MEDI-4736 following concurrent chemotherapy in patients with non small cell lung cancer.

Comments

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 and India 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.

Primary Endpoints

Met on 25 May 2018

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]

Met on 12 May 2017

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 is 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: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1

description: DoR is defined as the time from date for first documented response of Complete Response (CR) or Partial Response (PR) until the first documented response of progression per RECIST 1.1 or death in the absence of progression. time_frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1

description: APF12 is defined as the percentage of patients who are alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of progression free survival at 12 months. time_frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed 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 is defined as the percentage of patients who are alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of progression free survival at 18 months. time_frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed 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 is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis time_frame: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Overall Survival at 24 Months (OS24)

description: OS24 is defined as the number (%) of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months. At the date of the PFS interim analysis, the OS data were immature; therefore, analysis of OS was not performed for this interim analysis. Results of the first OS interim analysis (data cut-off: 22 March 2018) and associated outcomes will be included by March 2019. time_frame: Estimated to be from baseline up to 5 years [3]

Diseases Treated

Indication Qualifiers Patient Segments
Non-small cell lung cancer treatment consolidation therapy, stage III

Subjects

  • Subject Type patients
  • Number

    Planned: 880

    Actual: 713

  • Sex male & female
  • Age Group 23-90 (median 64) years; adult; elderly

Patient Inclusion Criteria

1. Provision of signed, written and dated informed consent prior to any study specific procedures 2. Male or female aged 18 years or older 3. Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease 4. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. 5. Patients must have not progressed following definitive, platinumbased, concurrent chemoradiation therapy. 6. Provision of an archived tumour tissue block where such samples exist in a quantity sufficient to allow for analysis. 7. Life expectancy ≥12 weeks 8. World Health Organization (WHO) Performance Status of 0 or 1 9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. 10. Adequate organ and marrow function

Patient Exclusion Criteria

1. Participation in another clinical study with an investigational product during the last 4 weeks 2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study 3. Mixed small cell and non-small cell lung cancer histology 4. Receipt of sequential chemoradiation therapy for locally advanced NSCLC 5. Patients with locally advanced NSCLC who have progressed whilst receiving definitive platinum based, concurrent chemoradiation therapy 6. Receipt of any immunotherapy, or investigational drug within 4 weeks prior to the first dose of study drug 7. Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required as prophylaxis against or to manage toxicities arising from chemotherapy and/or radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed. 8. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 9. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. 10. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included (eg, hearing loss) after consultation with the AstraZeneca/MedImmune medical monitor. 11. Patients with ≥grade 2 pneumonitis from prior chemoradiation therapy 12. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. 13. Recent major surgery within 4 weeks 14. Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment 15. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) 16. History of primary immunodeficiency 17. History of allogeneic organ transplant 18. History of hypersensitivity to MEDI4736 or any excipient 19. Uncontrolled intercurrent illness 20. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study drug. 21. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated in situ malignancies such as basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study 22. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control 23. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

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
  • Affiliations AstraZeneca; 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 : 09 Jul 2019

Substudies/Extensions

This trial contains a sub-study: Pharmacogenetics Research

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised; sequential
  • Phase of Trial Phase III
  • Location Argentina; Australia; Belgium; Brazil; Canada; Chile; China; Colombia; England; European Union; 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

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

Phase III:
In the phase III PACIFIC trial, durvalumab demonstrated a statistically-significant and clinically-meaningful improvement in progression free survival (PFS) (first primary end point) of 11.2 months, 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. Additionally, durvalumab also showed that PFS was reached by 51.1% patients compared to 73% patients in placebo [4] [5] [6] .

Adverse events

Phase III:
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 (35.4% versus 25.2%), pneumonitis/radiation pneumonitis (33.9% versus 24.8%), fatigue (23.8% 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 29.9% 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 [4] [5] [6] .

Publications

  1. 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
  2. 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
  3. 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
  4. 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
  5. AstraZeneca. US FDA APPROVES IMFINZI(R) (DURVALUMAB) FOR UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER. Media-Rel 2018;.

    Media Release
  6. 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
  7. 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
  8. 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
  9. 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
  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
  11. 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

Authors

Author Total Publications First Author Last Author
Abdullah SE 1 - -
Antonia S J 1 - 1
Antonia SJ 6 3 3
AstraZeneca 4 4 3
Boothman A-M 1 - -
Bourhaba M 2 - -
Chiappori A 2 - -
Cho BC 4 - -
Daniel D 6 - -
de Castro Carpeno J 2 - -
de Wit M 2 - -
Dennis P A 1 - -
Dennis PA 6 - -
Faivre-Finn C 3 1 -
Gray JE 2 - -
Hellmann MD 1 - -
Hiret S 2 - -
Huang Y 1 - -
Hui R 6 - -
Jiang H 1 - -
Karapetis CS 2 - -
Kim YC 2 - -
Kubota K 3 - -
Kurata T 1 - -
Langer C J 1 - -
Lee KH 3 - -
Lloyd A 1 - -
MedImmune 1 - 1
Mekhail T 2 - -
Melillo G 3 - -
Murakami S 6 - -
Naidoo J 1 - -
Ostoros G 2 - -
Ozguro?lu M 3 - -
Ozguroglu M 2 - 2
Paz-Ares L 5 - -
Perez B 1 - -
Planchard D 3 - -
Poole L 4 - -
Quantin X 2 - -
Raben D 1 - -
Reck M 2 - -
Rizvi NA 1 - 1
Senan S 1 - -
Spigel D R 1 - -
Spigel DR 2 1 -
Spira A 1 1 -
Taboada M 1 - -
Tokito T 2 - -
Vansteenkiste J 1 - -
Vansteenkiste JF 2 1 -
Vicente D 5 - -
Villegas A 6 - -
Wadsworth C 6 - -
Wakelee HA 1 - -
Yokoi T 1 - -
zguro?lu M O 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
show details
-
Cancer Study Locator
877 400 4656 AstraZeneca@emergingmed.com
show details
-
Giovanni Melillo, MD AstraZeneca
-
Information Centre
Södertälje
Södertälje
Postcode: SE 151 85
Sweden
information.centre@astrazeneca.com
show details
AstraZeneca AB Sweden
Marc Ballas
Phone: 800-236-9933
ClinicalTrialTransparency@astrazeneca.com
show details
AstraZeneca
-

Centres

Centre Name Location Trial Centre Country
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- 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
31 Jan 2019 Other trial event Last checked against the ClinicalTrials.gov record. Updated 31 Jan 2019
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
02 Jul 2018 Other trial event Last checked against the European Clinical Trials Database record. Updated 02 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

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