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AZD2936

Phase 1

Non-Small-Cell Lung Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 24, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment212
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04995523A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLCPHASE1 ACTIVE NOT_RECRUITING 212 — — Sep 14, 2021Jun 1, 2028Mar 24, 202640 United States, Australia +14
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Study Endpoints
Primary Endpoints
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig

A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Rate of rilvegostomig discontinuation due to toxicity
Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)

Percentage of participants with AEs leading to discontinuation of rilvegostomig

Objective Response Rate (ORR)
Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)

Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1

Secondary Endpoints
ORR
Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Disease control rate (DCR)
Part A, B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Duration of response (DoR)
Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)EXPERIMENTALRilvegostomig Intravenous (IV) monotherapy
Dose Expansion Part B: CPI experienced NSCLCEXPERIMENTALRilvegostomig IV monotherapy
Dose Expansion Part C: CPI Naive NSCLCEXPERIMENTALRilvegostomig IV monotherapy
Dose Expansion Part D: CPI Naive NSCLCEXPERIMENTALRilvegostomig IV monotherapy
Dose Expansion Part E: treatment Naive Squamous NSCLCEXPERIMENTALRilvegostomig IV monotherapy
Interventions
NameTypeDescription
AZD2936DRUGAnti-TIGIT/Anti-PD-1 Bispecific Antibody
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Written informed consent * Aged 18 or above * Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radi...

Countries:United StatesAustraliaBelgiumBrazilChinaDenmarkFranceGeorgiaJapanMalaysiaMoldovaNetherlandsSouth KoreaSpainTaiwanThailand
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04995523Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT04995523studyFirstPostDate: changed