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OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

NCT02654587 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2024-02-02

Study results available
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Summary

The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment.

The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)

Conditions

  • Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

OSE2101

DRUG

Docetaxel

DRUG

Pemetrexed

Sponsors & Collaborators

  • OSE Immunotherapeutics

    lead INDUSTRY

Principal Investigators

  • Dominique Costantini, Dr · OSE Immunotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-12
Primary Completion
2021-01-15
Completion
2021-01-15

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654587 on ClinicalTrials.gov