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S095018

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06162572Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)PHASE1 ACTIVE NOT_RECRUITING 102Aug 7, 2024Jul 1, 2027May 11, 202663 United States, Argentina +12
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06162572studyFirstPostDate: changed