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NCT04025879 · ClinicalTrials.gov registry record · Phase 3

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
461
Enrollment target
20
Study locations

NCT04025879: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Bristol-Myers Squibb.

NCT04025879 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 461 participants, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04025879, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
461 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Primary Outcome

The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other t

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • DRUG Paclitaxel
  • BIOLOGICAL Nivolumab

Study Locations (20)

Illinois

  • Local Institution - 0145 - Chicago
  • Local Institution - 0078 - Chicago
  • Local Institution - 0121 - Orland Park

Georgia

  • Local Institution - 0040 - Atlanta
  • Local Institution - 0120 - Augusta

Massachusetts

  • Local Institution - 0076 - Boston
  • Local Institution - 0074 - Newton

Ohio

  • Local Institution - 0055 - Cincinnati
  • Local Institution - 0102 - Cleveland

Other

  • Local Institution - 0043 - Buenos Aires
  • Local Institution - 0030 - CABA

Florida

  • Local Institution - 0104 - Tampa

Maryland

  • Rcca Md Llc - Bethesda

Michigan

  • Local Institution - 0086 - Traverse City

Trial Details

FieldValue
Enrollment Target 461 participants
Start Date 2019-11-05
Est. Completion 2027-07-30
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the registry record for NCT04025879 still lists

NCT04025879 is an interventional study that assigns participants to a tested intervention. The registered 461 participants enrollment target is mid-sized for trials with a published cap, above the 320-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (44% higher).

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04025879 names 20 study sites across 14 states, led by Illinois, Georgia, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04025879 about?

NCT04025879 is a clinical study titled "A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer". The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

What is the current status of trial NCT04025879?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 461 participants. The study started on 2019-11-05. Estimated completion is 2027-07-30.

What conditions does trial NCT04025879 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT04025879?

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

Who is sponsoring clinical trial NCT04025879?

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

Where is trial NCT04025879 being conducted?

This trial has 20 study locations across Florida, Georgia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04025879's enrollment target sits among peer trials

461 32nd of 130 higher than 99 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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Related registry views

Source: ClinicalTrials.gov NCT04025879, the US trial registry maintained by the National Library of Medicine. NCT04025879 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.