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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
210 participants
INTERVENTIONAL
2021-09-14
2028-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)
Rilvegostomig Intravenous (IV) monotherapy
AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Dose Expansion Part B: CPI experienced NSCLC
Rilvegostomig IV monotherapy
AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Dose Expansion Part C: CPI Naive NSCLC
Rilvegostomig IV monotherapy
AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Dose Expansion Part D: CPI Naive NSCLC
Rilvegostomig IV monotherapy
AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Dose Expansion Part E: treatment Naive Squamous NSCLC
Rilvegostomig IV monotherapy
AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Interventions
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AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Orange, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Rochester, Minnesota, United States
Research Site
Houston, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Melbourne, , Australia
Research Site
Anderlecht, , Belgium
Research Site
Leuven, , Belgium
Research Site
Florianópolis, , Brazil
Research Site
Natal, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Wuhan, , China
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Copenhagen, , Denmark
Research Site
Dijon, , France
Research Site
Toulouse, , France
Research Site
Tbilisi, , Georgia
Research Site
Kashiwa, , Japan
Research Site
Niigata, , Japan
Research Site
Sendai, , Japan
Research Site
Tokyo, , Japan
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Kuala Lumpur, , Malaysia
Research Site
Kuching, , Malaysia
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Chisinau, , Moldova
Research Site
Groningen, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Singapore, , Singapore
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Chanthaburi, , Thailand
Research Site
Muang, , Thailand
Research Site
Leicester, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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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
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