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S095018

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 11, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

S095018 · 1 trial · 1 indication

Phase 1 1
NCT06162572Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer (NSCLC)
ACTIVE NOT_RECRUITING102 Analytics
PHASE1ACTIVE NOT_RECRUITING
Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
NCT06162572102
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Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Objective Response (OR)
Until study termination (approximately 3 years)
Best Overall Response (BOR)
Until study termination (approximately 3 years)
Duration of Response (DoR)
Until study termination (approximately 3 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
S095018 (anti-TIM3 antibody) in combination with cemiplimabEXPERIMENTALPart A: Combination-therapy safety lead-in
S095024 (anti-CD73 antibody) in combination with cemiplimabEXPERIMENTALPart A: Combination-therapy safety lead-in
S095029 (anti-NKG2A antibody) in combination with cemiplimabEXPERIMENTALPart A: Combination-therapy safety lead-in
S095018 (anti-TIM3 antibody) RDE in combination with cemiplimabEXPERIMENTALPart B: Randomized dose expansion
S095024 (anti-CD73 antibody) RDE in combination with cemiplimabEXPERIMENTALPart B: Randomized dose expansion
S095029 (anti-NKG2A antibody) RDE in combination with cemiplimabEXPERIMENTALPart B: Randomized dose expansion
Cemiplimab (control arm)ACTIVE_COMPARATORPart B: Randomized dose expansion

Interventions

NameTypeDescription
S095018DRUGVia IV infusion on Day 1 of each 21-day cycle
S095024DRUGVia IV infusion on Day 1 of each 21-day cycle
S095029DRUGVia IV infusion on Day 1 of each 21-day cycle
S095018 Recommended Dose Expansion (RDE)DRUGVia IV infusion on Day 1 of each 21-day cycle
S095024 RDEDRUGVia IV infusion on Day 1 of each 21-day cycle
S095029 RDEDRUGVia IV infusion on Day 1 of each 21-day cycle
CemiplimabDRUG350 mg via IV infusion on Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * Adult patient aged ≥ 18 years * Written informed consent * Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC * No prior systemic treatment for l...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilFranceHong KongHungaryItalyRomaniaSpainTaiwanUnited Kingdom
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