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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

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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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Frequently asked questions about S095018

What is S095018 used for in Non-small Cell Lung Cancer?

S095018 is an investigational small molecule being studied for the treatment of Non-small Cell Lung Cancer (NSCLC). It is currently in Phase 1 clinical development as part of a platform study evaluating immunotherapy combinations in participants with advanced NSCLC.

Who makes S095018?

S095018 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker TNGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Non-small Cell Lung Cancer.

What phase is S095018 in?

S095018 is in Phase 1 clinical development. It is being evaluated in an active Phase 1b/2 platform study, though the drug itself is currently in the Phase 1 portion of this trial. It is an investigational agent and has not been approved by regulatory authorities.

What clinical trials is S095018 in?

S095018 is being studied in clinical trial NCT06162572, a Phase 1b/2 platform study of select immunotherapy combinations in participants with advanced Non-small Cell Lung Cancer. The trial is active but not recruiting, with an enrollment of 102 participants across multiple countries including the United States, Argentina, Australia, and several European and Asian countries.

Is S095018 the same as any other drug?

S095018 is a distinct investigational small molecule developed by Tango Therapeutics. No alternative names for this drug have been reported in the available clinical trial information. It is being studied specifically in combination with other immunotherapies for Non-small Cell Lung Cancer.