A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Locally Advanced (IIIB) Unsuitable for Radiotherapy or Metastatic (IV) Non-Small-Cell Lung Cancer. (OSE2101C301)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 13 Dec 2017
At a glance
- Drugs OSE 2101 (Primary) ; Docetaxel; Pemetrexed
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms ATALANTE-1
- Sponsors OSE Immunotherapeutics; OSE Pharma
- 07 Dec 2017 According to an OSE Immunotherapeutics media release, the IDMC recommendation also includes maintaining the hold on accrual of patients who have not received prior treatment with immune checkpoint inhibitors. Following formal approval from the Competent Authorities, patient accrual will resume exclusively in patients who have previously failed an ICI treatment.
- 07 Dec 2017 According to an OSE Immunotherapeutics media release, the Independent Data Monitoring Committee (IDMC) has recommended to the trial's steering committee that accrual of the trial could resume with a specified new recruitment strategy focused on a subgroup of patients who have failed a previous treatment with PD-1/PD-L1 immune checkpoint inhibitors (ICI).
- 02 Oct 2017 According to an OSE Immunotherapeutics media release, follow-up of patients is ongoing.