Status:
RECRUITING
Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Servier Bio-Innovation LLC
Collaborating Sponsors:
Institut de Recherches Internationales Servier
Regeneron Pharmaceuticals
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adul...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- History of hemophagocytic lymphohistiocytosis.
- Systemic chronic steroid therapy (\>10mg/d prednisone or equivalent)
- Clinically significant infection, as assessed by the investigator
- 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
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT06162572
Start Date
August 7 2024
End Date
July 1 2027
Last Update
January 8 2026
Active Locations (73)
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1
Loma Linda University
Loma Linda, California, United States, 92354
2
University of Kansas Medical Center
Lawrence, Kansas, United States, 66160
3
Henry Ford Health
Detroit, Michigan, United States, 48202
4
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89119