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Active (not recruiting) Phase 2 NCT04623775

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)

Phase 2 – studying effectiveness and dosage
Conditions: Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 18
Argentina (1)
Local Institution - 0037
Río Cuarto , Córdoba Province
Australia (1)
Local Institution - 0055
Camperdown , New South Wales
Belgium (1)
Local Institution - 0127
Ghent
Brazil (1)
Local Institution - 0063
Natal , Rio Grande do Norte
Chile (1)
Local Institution - 0079
Santiago , Santiago Metropolitan
France (1)
Local Institution - 0008
Rennes , Ille-Et-Vilaine
Germany (1)
Local Institution - 0065
Essen , North Rhine-Westphalia
Ireland (1)
Local Institution - 0133
Elm Park , Dublin
Italy (1)
Local Institution - 0106
Rome , RA
Mexico (1)
Local Institution - 0070
Mexico City , Mexico City
Netherlands (1)
Local Institution - 0053
Harderwijk , Gelderland
Poland (1)
Local Institution - 0145
Gdynia
Romania (1)
Local Institution - 0099
Cluj-Napoca , Cluj
Russia (1)
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk
Spain (1)
Local Institution - 0075
Seville , Andalusia
Switzerland (1)
Local Institution - 0015
Basel
United Kingdom (1)
Local Institution - 0135
Middlesbrough , Cleveland
United States (1)
Local Institution - 0160
Duarte , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.02.2021
Completion date
27.02.2026
Registry ID
NCT04623775
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.