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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Servier Bio-Innovation LLC
Study ID
NCT06162572
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Aug 7, 2024
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: S095018 (anti-TIM3 antibody) in combination with cemiplimab
    Part A: Combination-therapy safety lead-in
  • Experimental: S095024 (anti-CD73 antibody) in combination with cemiplimab
    Part A: Combination-therapy safety lead-in
  • Experimental: S095029 (anti-NKG2A antibody) in combination with cemiplimab
    Part A: Combination-therapy safety lead-in
  • Experimental: S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab
    Part B: Randomized dose expansion
  • Experimental: S095024 (anti-CD73 antibody) RDE in combination with cemiplimab
    Part B: Randomized dose expansion
  • Experimental: S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab
    Part B: Randomized dose expansion
  • Active Comparator: Cemiplimab (control arm)
    Part B: Randomized dose expansion

Primary Outcome Measure

Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment [ Time Frame: Through the end of the Cycle 2 (each cycle is 21 days) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92354-
Henry Ford HealthDetroitMichigan48202-
Comprehensive Cancer Center of NevadaLas VegasNevada89119-
Gabrail Cancer CenterCantonOhio44718-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Virginia Cancer Specialists, P.C.FairfaxVirginia22031-

Find similar trials in Loma Linda, CA

By research site
Loma Linda University· Loma Linda, CAHenry Ford Health· Detroit, MIComprehensive Cancer Center of Nevada· Las Vegas, NVGabrail Cancer Center· Canton, OHOhio State University Comprehensive Cancer Center· Columbus, OHVirginia Cancer Specialists, P.C.· Fairfax, VA

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