Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

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.

NCT Number	NCT06162572
Lead Sponsor	Servier Bio-Innovation LLC Collaborators: Institut de Recherches Internationales Servier, Regeneron Pharmaceuticals
Conditions	Non-small Cell Lung Cancer (NSCLC)
Enrollment	102 participants
Start Date	2024-08-07
Primary Completion	2027-04 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-11