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)

  • STATUS
    Recruiting
  • End date
    Oct 30, 2025
  • participants needed
    420
  • sponsor
    Bristol-Myers Squibb
Updated on 21 October 2022
paclitaxel
measurable disease
growth factor
pemetrexed
carboplatin
epidermal growth factor receptor
EGFR
nivolumab
cancer treatment
cancer chemotherapy
epidermal growth factor
platinum doublet
recurrent non-small cell lung cancer
lung carcinoma

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).

Details
Condition Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
Treatment cisplatin, carboplatin, Paclitaxel, Pemetrexed, Nab-paclitaxel, Nivolumab, Relatlimab
Clinical Study IdentifierNCT04623775
SponsorBristol-Myers Squibb
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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