Last updated 13 days ago
Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
176 patients around the world
Available in Brazil, Argentina
Servier Bio-Innovation LLC
13Research sites
176Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Adult patient aged ≥ 18 years.Written informed consent.Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC.No prior systemic treatment for locally advanced or metastatic NSCLC.High tumor cell PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] based on documented status as determined by an approved test.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.Measurable disease as determined by RECIST v1.1.
- Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations).Prior immune checkpoint inhibitor therapy.Active brain metastases.Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll.Active, known or suspected autoimmune disease or immune deficiency.History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients.History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2.History of inflammatory bowel disease or colitis ≥ grade 2.Systemic chronic steroid therapy (>10mg/d prednisone or equivalent).Active infection, including infection requiring systemic antibiotic therapy.Pregnant or breast-feeding (lactating) women.Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant).Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study.
Sites
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Sanatorio Parque S.A. Tucumán
Hospital de Amor
Supera Centro de Oncologia e Mastologia
CIONC - Centro Integrado de Oncología de Curitiba
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Oncoclínicas
SponsorServier Bio-Innovation LLC
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06162572
