A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

NCT ID: NCT04995523

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2028-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small-Cell Lung Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The study includes 5 parts: Part A: Dose escalation; B \& C \& E: Dose expansion non-randomized; D: Randomized RP2D \& alternative dose.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)

Rilvegostomig Intravenous (IV) monotherapy

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Dose Expansion Part B: CPI experienced NSCLC

Rilvegostomig IV monotherapy

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Dose Expansion Part C: CPI Naive NSCLC

Rilvegostomig IV monotherapy

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Dose Expansion Part D: CPI Naive NSCLC

Rilvegostomig IV monotherapy

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Dose Expansion Part E: treatment Naive Squamous NSCLC

Rilvegostomig IV monotherapy

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2936

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rilvegostomig

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Orange, California, United States

Site Status WITHDRAWN

Research Site

Chicago, Illinois, United States

Site Status RECRUITING

Research Site

Baltimore, Maryland, United States

Site Status WITHDRAWN

Research Site

Rochester, Minnesota, United States

Site Status RECRUITING

Research Site

Houston, Texas, United States

Site Status WITHDRAWN

Research Site

Fairfax, Virginia, United States

Site Status RECRUITING

Research Site

Melbourne, , Australia

Site Status COMPLETED

Research Site

Anderlecht, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Research Site

Leuven, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Research Site

Florianópolis, , Brazil

Site Status RECRUITING

Research Site

Natal, , Brazil

Site Status RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status RECRUITING

Research Site

Rio de Janeiro, , Brazil

Site Status RECRUITING

Research Site

São Paulo, , Brazil

Site Status RECRUITING

Research Site

Chengdu, , China

Site Status RECRUITING

Research Site

Chongqing, , China

Site Status ACTIVE_NOT_RECRUITING

Research Site

Wuhan, , China

Site Status WITHDRAWN

Research Site

Copenhagen, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Research Site

Dijon, , France

Site Status RECRUITING

Research Site

Toulouse, , France

Site Status RECRUITING

Research Site

Tbilisi, , Georgia

Site Status RECRUITING

Research Site

Kashiwa, , Japan

Site Status RECRUITING

Research Site

Niigata, , Japan

Site Status RECRUITING

Research Site

Sendai, , Japan

Site Status RECRUITING

Research Site

Tokyo, , Japan

Site Status RECRUITING

Research Site

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Research Site

Kuching, , Malaysia

Site Status RECRUITING

Research Site

Chisinau, , Moldova

Site Status RECRUITING

Research Site

Groningen, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Research Site

Leiden, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Research Site

Utrecht, , Netherlands

Site Status COMPLETED

Research Site

Singapore, , Singapore

Site Status WITHDRAWN

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Research Site

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Research Site

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Tainan, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status WITHDRAWN

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Bangkok, , Thailand

Site Status RECRUITING

Research Site

Chanthaburi, , Thailand

Site Status RECRUITING

Research Site

Muang, , Thailand

Site Status RECRUITING

Research Site

Leicester, , United Kingdom

Site Status WITHDRAWN

Research Site

Manchester, , United Kingdom

Site Status WITHDRAWN

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Brazil China Denmark France Georgia Japan Malaysia Moldova Netherlands Singapore South Korea Spain Taiwan Thailand United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-508262-15-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-000857-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D7020C00001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.