Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Non-small Cell Lung Cancer (NSCLC)
In brief
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 adult participants with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (RDE) for S095018, S095024, and S095029 in combination with cemiplimab and part B, the randomized dose expansion phase to assess the efficacy of S095018, S095024, or S095029 in combination with cemiplimab. Study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per iRECIST and/ or until meeting other treatment discontinuation criteria.
Key facts
- Study ID
- NCT06162572
- Run by
- Servier Bio-Innovation LLC
- People needed
- 102
- Starts
- 2024-08-07
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Henry Ford Health — Detroit, Michigan, United States
- Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
- Gabrail Cancer Center — Canton, Ohio, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Virginia Cancer Specialists, P.C. — Fairfax, Virginia, United States
- Instituto Médico Especializado Alexander Fleming — Buenos Aires, Argentina
- Sanatorio Parque S.A. — Santa Fe, Argentina
- Border Medical Oncology Research Unit — Albury, Australia
- Flinders Medical Centre — Bedford Park, Australia
- Sunshine Hospital — St Albans, Australia
- Latrobe Regional Health — Traralgon, Australia
- Ordensklinikum Linz Elisabethinen — Linz, Austria
- Universitatsklinikum St. Poelten — Sankt Pölten, Austria
- Medical University of Vienna - Akh — Vienna, Austria
- Jessa Ziekenhuis — Hasselt, Belgium
- Uz Leuven Campus Gasthuisberg — Leuven, Belgium
- Hospital de Amor - Barretos — Barretos, Brazil
- Supera Oncologia — Chapecó, Brazil
- CIONC — Curitiba, Brazil
- Liga Contra O Cancer - Natal — Natal, Brazil
- Santa Casa de Porto Alegre — Porto Alegre, Brazil
- Hospital São Lucas Da Pucrs — Porto Alegre, Brazil
- Oncoclinicas Rj — Rio de Janeiro, Brazil
- Hospital A C Camargo — São Paulo, Brazil
- Loma Linda University — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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