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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT04995523

Run by

AstraZeneca

People needed

212

Starts

2021-09-14

Expected to finish

2028-06-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Madrid, Spain
• Research Site — Madrid, Spain
• Research Site — Taichung, Taiwan
• Research Site — Taichung, Taiwan
• Research Site — Tainan, Taiwan
• Research Site — Barcelona, Spain
• Research Site — Chicago, Illinois, United States
• Research Site — Rochester, Minnesota, 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 — Copenhagen, Denmark
• Research Site — Dijon, France
• Research Site — Toulouse, France
• Research Site — Tbilisi, Georgia
• Research Site — Kashiwa, Japan
• Research Site — Niigata, Japan

Full record on ClinicalTrials.gov

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