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

Condition(s) studied

Investigational drug(s) / intervention(s)

S095018: Via IV infusion on Day 1 of each 21-day cycle

S095024: Via IV infusion on Day 1 of each 21-day cycle

S095029: Via IV infusion on Day 1 of each 21-day cycle

S095018 Recommended Dose Expansion (RDE): Via IV infusion on Day 1 of each 21-day cycle

S095024 RDE: Via IV infusion on Day 1 of each 21-day cycle

S095029 RDE: Via IV infusion on Day 1 of each 21-day cycle

Cemiplimab: 350 mg via IV infusion on Day 1 of each 21-day cycle

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.

Eligibility

Primary outcome measure(s)

• Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment — Through the end of the Cycle 2 (each cycle is 21 days)
  Part A
• Incidence and severity of adverse events (AEs) — From the signed informed consent form (ICF) to 30 days after the last dose
  Part A
• Incidence and severity of serious adverse events (SAEs) — From the signed ICF to 120 days after the last dose
  Part A
• Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays — From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
  Part A
• Adverse Events (AEs) Leading to Permanent Treatment Discontinuation — From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
  Part A
• Objective Response (OR) — Until study termination (approximately 2 years)
  Part B: Participants who achieve complete response (CR) or partial response (PR), as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Trial sites (56)

+ 16 more sites — see the full list on the official registry below.

On this site

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