A study to evaluate novel immunotherapy combinations in participants with advanced non-small cell lung cancer (NSCLC)

Phase 1

Recruiting

• Conditions: on-small cell lung cancer (NSCLC):- Locally advanced NSCLC where participants are not candidates for surgical resection and/or definitive chemoradiation, or- Metastatic NSCLC; MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508730-34-00
• Lead Sponsor: Institut De Recherches Internationales Servier IRIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-26
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

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, Adult participants (must be =18 years of age or according to local requirement), Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, Measurable disease as determintaed by RECIST v1.1

Exclusion Criteria

Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g., EGFR mutation, ALK fusion oncogene, ROS1 aberrations), 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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified