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NCT04026412 · ClinicalTrials.gov registry record · Phase 3

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

A Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
925
Enrollment target
20
Study locations

NCT04026412: Completed Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb.

NCT04026412 is a Phase 3 study of Non-small Cell Lung Cancer (NSCLC) that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 925 participants, above the 269-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (244% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04026412, a Phase 3 study of Non-small Cell Lung Cancer (NSCLC), has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
925 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Primary Outcome

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In additio

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • BIOLOGICAL nivolumab
  • BIOLOGICAL durvalumab
  • BIOLOGICAL ipilimumab

Study Locations (20)

Ohio

  • Local Institution - 0053 - Cincinnati
  • Local Institution - 0131 - Cincinnati
  • Local Institution - 0188 - Cincinnati
  • Local Institution - 0112 - Cleveland
  • Local Institution - 0124 - Cleveland
  • Local Institution - 0047 - Cleveland
  • Local Institution - 0123 - Youngstown

California

  • Local Institution - 0119 - La Jolla
  • Local Institution - 0207 - San Francisco
  • Local Institution - 0166 - San Francisco

Florida

  • Local Institution - 0233 - Jacksonville
  • Local Institution - 0219 - Orlando
  • Local Institution - 0039 - Pensacola

Georgia

  • Local Institution - 0125 - Atlanta
  • Local Institution - 0165 - Augusta

Colorado

  • Local Institution - 0129 - Lone Tree

Kentucky

  • Local Institution - 0218 - Edgewood

Maryland

  • Local Institution - 0108 - Bethesda

Michigan

  • Local Institution - 0116 - Traverse City

Trial Details

FieldValue
Enrollment Target 925 participants
Start Date 2019-10-08
Est. Completion 2024-11-26
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT04026412 record still lists

NCT04026412 is an interventional study that assigns participants to a tested intervention. The registered 925 participants enrollment target is mid-sized for trials with a published cap, above the 269-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (244% higher).

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 3 interventions - of which nivolumab is the first listed.

NCT04026412 names 20 study sites across 9 states, led by Ohio, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04026412 about?

NCT04026412 is a clinical study titled "A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery". The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

What is the current status of trial NCT04026412?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 925 participants. The study started on 2019-10-08. Estimated completion is 2024-11-26.

What conditions does trial NCT04026412 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT04026412?

The interventions under investigation include: nivolumab (BIOLOGICAL), durvalumab (BIOLOGICAL), ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04026412?

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

Where is trial NCT04026412 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-small Cell Lung Cancer (NSCLC)

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 NCT04026412's enrollment target sits among peer trials

925 4th of 59 higher than 56 of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) 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 NCT04026412, the US trial registry maintained by the National Library of Medicine. NCT04026412 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.