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NCT01673867 · ClinicalTrials.gov registry record · Phase 3

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

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

Completed
Registry status
Phase 3
Development phase
582
Enrollment target

NCT01673867: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT01673867 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 582 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01673867, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
582 participants
Enrollment target

Study Summary

The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

Primary Outcome

Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.

Interventions

  • DRUG Docetaxel
  • BIOLOGICAL Nivolumab

Trial Details

FieldValue
Enrollment Target 582 participants
Start Date 2012-11-02
Est. Completion 2021-12-17
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01673867 record still lists

NCT01673867 is an interventional study that assigns participants to a tested intervention. The registered 582 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 (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.

NCT01673867 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01673867 about?

NCT01673867 is a clinical study titled "Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC". The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

What is the current status of trial NCT01673867?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2012-11-02. Estimated completion is 2021-12-17.

What interventions are being tested in trial NCT01673867?

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

Who is sponsoring clinical trial NCT01673867?

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 NCT01673867's enrollment target sits among peer trials

582 653rd of 2000 higher than 1,345 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 NCT01673867, the US trial registry maintained by the National Library of Medicine. NCT01673867 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.