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NCT02864251 · ClinicalTrials.gov registry record · Phase 3

A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
367
Enrollment target

NCT02864251: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT02864251 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 367 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02864251, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
367 participants
Enrollment target

Study Summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Primary Outcome

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance o

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Trial Details

FieldValue
Enrollment Target 367 participants
Start Date 2017-03-17
Est. Completion 2022-10-17
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT02864251 record still lists

NCT02864251 is an interventional study that assigns participants to a tested intervention. The registered 367 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 (52% lower).

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT02864251 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02864251 about?

NCT02864251 is a clinical study titled "A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy". The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

What is the current status of trial NCT02864251?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2017-03-17. Estimated completion is 2022-10-17.

What interventions are being tested in trial NCT02864251?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02864251?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02864251's enrollment target sits among peer trials

367 998th of 2000 higher than 1,002 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 NCT02864251, the US trial registry maintained by the National Library of Medicine. NCT02864251 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.