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NCT04623775 · ClinicalTrials.gov registry record · Phase 2

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 2
Development phase
468
Enrollment target
20
Study locations

NCT04623775: Active Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb.

NCT04623775 is a Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 468 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04623775, a Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
468 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Primary Outcome

Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0.

Conditions Studied

Non-Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Relatlimab

Study Locations (20)

New York

  • Local Institution - 0124 - Johnson City
  • Local Institution - 0162 - Mineola
  • Local Institution - 0128 - New York
  • Local Institution - 0165 - New York
  • Local Institution - 0097 - The Bronx

California

  • Local Institution - 0160 - Duarte
  • Local Institution - 0081 - Orange

Florida

  • Local Institution - 0153 - Jacksonville
  • Local Institution - 0011 - Port Saint Lucie

Kentucky

  • Local Institution - 0159 - Lexington
  • Local Institution - 0002 - Louisville

Ohio

  • Local Institution - 0156 - Cincinnati
  • Local Institution - 0155 - Cleveland

Connecticut

  • Local Institution - 0139 - New Haven

Georgia

  • Local Institution - 0089 - Athens

Kansas

  • Local Institution - 0121 - Wichita

Trial Details

FieldValue
Enrollment Target 468 participants
Start Date 2021-02-17
Est. Completion 2026-02-27
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the registry record for NCT04623775 still lists

NCT04623775 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (28% lower).

The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04623775 names 20 study sites across 12 states, led by New York, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04623775 about?

NCT04623775 is a clinical study titled "A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)". The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in particip...

What is the current status of trial NCT04623775?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 468 participants. The study started on 2021-02-17. Estimated completion is 2026-02-27.

What conditions does trial NCT04623775 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer.

What interventions are being tested in trial NCT04623775?

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

Who is sponsoring clinical trial NCT04623775?

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

Where is trial NCT04623775 being conducted?

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

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung Cancer

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 NCT04623775's enrollment target sits among peer trials

468 87th of 454 higher than 368 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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 NCT04623775, the US trial registry maintained by the National Library of Medicine. NCT04623775 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.