NCT06162572

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

A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Servier Bio-Innovation LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	S095018	Via IV infusion on Day 1 of each 21-day cycle
DRUG	S095024	Via IV infusion on Day 1 of each 21-day cycle
DRUG	S095029	Via IV infusion on Day 1 of each 21-day cycle
DRUG	S095018 Recommended Dose Expansion (RDE)	Via IV infusion on Day 1 of each 21-day cycle
DRUG	S095024 RDE	Via IV infusion on Day 1 of each 21-day cycle
DRUG	S095029 RDE	Via IV infusion on Day 1 of each 21-day cycle
DRUG	Cemiplimab	350 mg via IV infusion on Day 1 of each 21-day cycle

Timeline

• Start date: 2024-08-07
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2023-12-08
• Last updated: 2026-04-03

Locations

63 sites across 14 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, France, Hong Kong, Hungary, Italy, Romania, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study