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

NCT06162572 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Servier Bio-Innovation LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2027-04-30
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • France
  • Hong Kong
  • Hungary
  • Italy
  • Romania
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162572 on ClinicalTrials.gov