A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Non-Small-Cell Lung Carcinoma
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Age range
- 18 years - 130 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 212 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
Read the full description
This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
- Documented PD-L1 expression by PD-L1 IHC per local report.
- Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
- Part C and Part D: No prior I/O treatment for metastatic NSCLC.
- Part E: No prior treatment for metastatic NSCLC.
- ECOG performance status of 0 or 1 at enrolment.
- Life expectancy of ≥ 12 weeks at enrolment.
- Have at least 1 measurable lesion per RECIST v1.1.
- Adequate bone marrow, liver and kidney function
Exclusion Criteria:
- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
- Previous treatment with an anti-TIGIT therapy
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
- Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).
Treatment with one previous systemic chemotherapy will be allowed.
- Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
- Symptomatic central nervous system (CNS) metastasis.
- Thromboembolic event within 3 months prior to enrolment.
- Other invasive malignancy within 2 years prior to screening.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)
Rilvegostomig Intravenous (IV) monotherapy
Drug: AZD2936
Dose Expansion Part B: CPI experienced NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part C: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part D: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
Dose Expansion Part E: treatment Naive Squamous NSCLC
Rilvegostomig IV monotherapy
Drug: AZD2936
AZD2936 DRUG
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Time frame: 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
Time frame: 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)
Time frame: 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 measures
ORR
Time frame: Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Percentage of participants with a confirmed CR or PR according to RECIST v1.1
Disease control rate (DCR)
Time frame: 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).
Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment
Duration of response (DoR)
Time frame: 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).
The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression
Durable response rate (DRR)
Time frame: 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).
The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more
Progression-free survival (PFS)
Time frame: Part 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).
The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Time frame: Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
Evaluation of the target engagement of rilvegostomig in peripheral blood
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Maximum observed plasma concentration of rilvegostomig
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Area under the plasma concentration-time curve
PK of rilvegostomig: Clearance
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Terminal elimination half life
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Immunogenicity of rilvegostomig
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (40)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
40 locations
Research SiteChicago, Illinois, United StatesStatus unknown
Research SiteRochester, Minnesota, United StatesStatus unknown
Research SiteFairfax, Virginia, United StatesStatus unknown
Research SiteMelbourne, AustraliaStatus unknown
Research SiteAnderlecht, BelgiumStatus unknown
Research SiteLeuven, BelgiumStatus unknown
Research SiteFlorianópolis, BrazilStatus unknown
Research SiteNatal, BrazilStatus unknown
Research SitePorto Alegre, BrazilStatus unknown
Research SiteRio de Janeiro, BrazilStatus unknown
Research SiteSão Paulo, BrazilStatus unknown
Research SiteChengdu, ChinaStatus unknown
Research SiteChongqing, ChinaStatus unknown
Research SiteCopenhagen, DenmarkStatus unknown
Research SiteDijon, FranceStatus unknown
Research SiteToulouse, FranceStatus unknown
Research SiteTbilisi, GeorgiaStatus unknown
Research SiteKashiwa, JapanStatus unknown
Research SiteNiigata, JapanStatus unknown
Research SiteSendai, JapanStatus unknown
Research SiteTokyo, JapanStatus unknown
Research SiteKuala Lumpur, MalaysiaStatus unknown
Research SiteKuching, MalaysiaStatus unknown
Research SiteChisinau, MoldovaStatus unknown
Research SiteGroningen, NetherlandsStatus unknown
Research SiteLeiden, NetherlandsStatus unknown
Research SiteUtrecht, NetherlandsStatus unknown
Research SiteSeoul, South KoreaStatus unknown
Research SiteSeoul, South KoreaStatus unknown
Research SiteSeoul, South KoreaStatus unknown
Research SiteBarcelona, SpainStatus unknown
Research SiteMadrid, SpainStatus unknown
Research SiteMadrid, SpainStatus unknown
Research SiteTaichung, TaiwanStatus unknown
Research SiteTaichung, TaiwanStatus unknown
Research SiteTainan, TaiwanStatus unknown
Research SiteTaipei, TaiwanStatus unknown
Research SiteBangkok, ThailandStatus unknown
Research SiteChanthaburi, ThailandStatus unknown
Research SiteMuang, ThailandStatus unknown
Study team and timeline
- Lead sponsor
- AstraZeneca
- Study start
- Sep 14, 2021 Actual
- Primary completion
- Jun 1, 2028 Estimated
- Study completion
- Jun 1, 2028 Estimated
- First posted
- Aug 9, 2021 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026