Study Comparing Relatlimab and Nivolumab with Chemotherapy to Nivolumab with Chemotherapy for First-Line Treatment of Advanced or Returning Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04623775
This clinical trial is testing whether adding the drug relatlimab to nivolumab and chemotherapy is safe and more effective in treating patients with advanced or returning non-small cell lung cancer (NSCLC) compared to using nivolumab with chemotherapy alone.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The goal of this study is to evaluate the safety of using a combination of the drugs relatlimab and nivolumab with standard chemotherapy in patients with advanced or returning non-small cell lung cancer (NSCLC). Researchers want to see if this combination can improve the overall response rate, which means how well the cancer responds to treatment, compared to using nivolumab with chemotherapy alone.
Eligibility Criteria
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.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
