Brief Summary
This is a Phase 1b/2 study evaluating the anti-PD1 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with previously untreated advancedat a late stage, far along/metastatic non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dosethe amount of medication taken 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.
Intervention / Treatment
- Drug: S095018
- Drug: S095024
- Drug: S095029
- Drug: S095018 Recommended Dose Expansion (RDE)
- Drug: S095024 RDE
- Drug: S095029 RDE
- Drug: Cemiplimab
Inclusion Criteria:
- Adult patient aged ≥ 18 years
- Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resectionsurgical removal of tissue or part/all of an organ 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1
- Measurable disease as determined by RECIST v1.1