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NCT02654587 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by OSE Immunotherapeutics.

Terminated
Registry status
Phase 3
Development phase
219
Enrollment target

NCT02654587: Clinical Trial Phase 3 study, sponsored by OSE Immunotherapeutics.

NCT02654587 is a Phase 3 study that was terminated before completion, run by OSE Immunotherapeutics. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02654587, a Phase 3 study, was terminated before completion, sponsored by OSE Immunotherapeutics.

TERMINATED
Registry status
Phase 3
Development phase
219 participants
Enrollment target

Study 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)

Primary Outcome

OS defined as the time from randomisation to death from any cause in patients with ICI secondary resistance

Interventions

  • DRUG Docetaxel
  • DRUG Pemetrexed
  • BIOLOGICAL OSE2101

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 2016-02-12
Est. Completion 2021-01-15
Phase Phase 3
OSE Immunotherapeutics

2 total trials

Why NCT02654587 stopped before completion

NCT02654587 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.

NCT02654587 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02654587 about?

NCT02654587 is a clinical study titled "OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure". 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 ...

What is the current status of trial NCT02654587?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2016-02-12. Estimated completion is 2021-01-15.

What interventions are being tested in trial NCT02654587?

The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), OSE2101 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02654587?

This trial is sponsored by OSE Immunotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02654587's enrollment target sits among peer trials

219 1329th of 2000 higher than 670 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02654587, the US trial registry maintained by the National Library of Medicine. NCT02654587 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.