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)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2

Conditions

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

Treatments

Drug: Pemetrexed
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Biological: Relatlimab
Biological: Nivolumab
Drug: Nab-Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04623775
CA224-104
2020-004026-31 (EudraCT Number)
U1111-1256-8115 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

420 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization
  • Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria
  • No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease

Exclusion criteria

  • Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy
  • Untreated CNS metastases
  • Leptomeningeal metastases (carcinomatous meningitis)
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease)
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

420 participants in 4 patient groups

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Experimental group
Treatment:
Drug: Nab-Paclitaxel
Biological: Nivolumab
Biological: Relatlimab
Drug: Paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Experimental group
Treatment:
Drug: Nab-Paclitaxel
Biological: Nivolumab
Biological: Relatlimab
Drug: Paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Experimental group
Treatment:
Biological: Nivolumab
Biological: Relatlimab
Drug: Paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Part 2: Arm D (Nivolumab + PDCT)
Active Comparator group
Treatment:
Biological: Nivolumab
Drug: Paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed

Trial contacts and locations

127

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Central trial contact

BMS Study Connect Contact Center http://www.bmsstudyconnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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