CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 468 enrolled / 468 target
Drug / intervention
Nivolumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04623775
NCT04623775Phase 2CompletedMonitor (7.3/mo)Completion was 29mo ago
CompareCT.gov

A Phase 2 Randomized 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)

Bristol-Myers Squibb·interventional·Posted Nov 10, 2020·Updated Jun 18, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Relatlimab, and 5 other interventions for Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 468 participants across 125 sites in 19 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 10, 2020
Enrollment StartFeb 17, 2021
Primary CompletionJan 11, 2024
Study CompletionMay 6, 2026
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.6 years ago

Arms & Interventions

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))experimental

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-PaclitaxelDrug: Pemetrexed
Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))experimental

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-PaclitaxelDrug: Pemetrexed
Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)experimental

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Pemetrexed
Part 2: Arm D (Nivolumab + PDCT)active_comparator

Biological: NivolumabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Pemetrexed

Interventions

Nivolumabbiological

Specified dose on specified days

Relatlimabbiological

Specified dose on specified days

Carboplatindrug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Cisplatindrug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Paclitaxeldrug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Nab-Paclitaxeldrug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Pemetrexeddrug

Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.