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

Last updated: March 20, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Treatment

AZD2936

Clinical Study ID

NCT04995523
D7020C00001
2023-508262-15-00
2021-000857-23
  • Ages 18-130
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent

  • Aged 18 or above

  • Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLCnot amenable to curative surgery or radiation. Part C and Part D: Stage IV squamousor non-squamous NSCLC not amenable to curative surgery or radiation. Part E: StageIV 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-includingregimen.

  • 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

Exclusion Criteria:

  • Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphomakinase (ALK) fusion

  • Documented test result for any other known genomic alteration for which a targetedtherapy is approved in first line per local standard of care (e.g. ROS1, NTRKfusions, BRAF, V600E mutation)

  • Previous treatment with an anti-TIGIT therapy

  • Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonaltherapy for cancer treatment.

  • Part A and Part B: Primary or secondary resistance after treatment with 2 or moreregiments including a CPI.

  • Part C and Part D: Any prior systemic treatment with an immune oncology agent (prioradministration of immune-oncology agent for curative intent to treat other invasivemalignancy is permitted).

Treatment with one previous systemic chemotherapy will be allowed.

  • Part E: Any prior systemic treatment for metastatic NSCLC, including but not limitedto 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.

Study Design

Total Participants: 212
Treatment Group(s): 1
Primary Treatment: AZD2936
Phase: 1/2
Study Start date:
September 14, 2021
Estimated Completion Date:
June 01, 2028

Study 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).

Connect with a study center

  • Research Site

    Melbourne, 3000
    Australia

    Site Not Available

  • Research Site

    Melbourne 2158177, 3000
    Australia

    Site Not Available

  • Research Site

    Anderlecht, 1070
    Belgium

    Site Not Available

  • Research Site

    Anderlecht 2803201, 1070
    Belgium

    Site Not Available

  • Research Site

    Bruxelles, 1000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Research Site

    Florianópolis, 88034-000
    Brazil

    Site Not Available

  • Research Site

    Florianópolis 3463237, 88034-000
    Brazil

    Site Not Available

  • Research Site

    Natal, 59075-740
    Brazil

    Site Not Available

  • Research Site

    Natal 3394023, 59075-740
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre 3452925, 90035903
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro 3451190, 20231-050
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 01246-000
    Brazil

    Site Not Available

  • Research Site

    Chengdu, 610041
    China

    Site Not Available

  • Research Site

    Chengdu 1815286, 610041
    China

    Site Not Available

  • Research Site

    Chongqing, 400030
    China

    Site Not Available

  • Research Site

    Chongqing 1814906, 400030
    China

    Site Not Available

  • Research Site

    Wuhan, 430022
    China

    Site Not Available

  • Research Site

    Wuhan 1791247, 430022
    China

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Research Site

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Research Site

    Dijon, 21079
    France

    Site Not Available

  • Research Site

    Dijon 3021372, 21079
    France

    Site Not Available

  • Research Site

    Toulouse, 31059
    France

    Site Not Available

  • Research Site

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Research Site

    Toulouse Cedex 09, 31059
    France

    Site Not Available

  • Research Site

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Research Site

    Tbilisi 611717, 0112
    Georgia

    Site Not Available

  • Research Site

    Kashiwa, 227-8577
    Japan

    Site Not Available

  • Research Site

    Kashiwa 1859924, 227-8577
    Japan

    Site Not Available

  • Research Site

    Niigata, 951-8566
    Japan

    Site Not Available

  • Research Site

    Niigata 1855431, 951-8566
    Japan

    Site Not Available

  • Research Site

    Niigata-shi, 951-8566
    Japan

    Site Not Available

  • Research Site

    Sendai, 981-0914
    Japan

    Site Not Available

  • Research Site

    Sendai 2111149, 981-0914
    Japan

    Site Not Available

  • Research Site

    Sendai-shi, 981-0914
    Japan

    Site Not Available

  • Research Site

    Tokyo, 104-0045
    Japan

    Site Not Available

  • Research Site

    Tokyo 1850147, 104-0045
    Japan

    Site Not Available

  • Research Site

    Seoul, 03082
    Korea, Republic of

    Site Not Available

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuala Lumpur 1735161, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuching, 93586
    Malaysia

    Site Not Available

  • Research Site

    Kuching 1735634, 93586
    Malaysia

    Site Not Available

  • Research Site

    Chisinau, MD-2025
    Moldova

    Site Not Available

  • Research Site

    Chisinau 618426, MD-2025
    Moldova

    Site Not Available

  • Research Site

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • Research Site

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Research Site

    Groningen 2755251, 9713 GZ
    Netherlands

    Site Not Available

  • Research Site

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Research Site

    Leiden 2751773, 2333 ZA
    Netherlands

    Site Not Available

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Research Site

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Research Site

    Utrecht 2745912, 3584 CX
    Netherlands

    Site Not Available

  • Research Site

    Singapore, 308433
    Singapore

    Site Not Available

  • Research Site

    Singapore 1880252, 308433
    Singapore

    Site Not Available

  • Research Site

    Seoul, 03082
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Research Site

    Taichung,
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399,
    Taiwan

    Site Not Available

  • Research Site

    Tainan, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan City, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan City 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 110
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 110
    Taiwan

    Site Not Available

  • Research Site

    Bangkok, 10700
    Thailand

    Site Not Available

  • Research Site

    Bangkok 1609350, 10700
    Thailand

    Site Not Available

  • Research Site

    Chanthaburi, 22000
    Thailand

    Site Not Available

  • Research Site

    Chanthaburi 1611269, 22000
    Thailand

    Site Not Available

  • Research Site

    Muang, 50200
    Thailand

    Site Not Available

  • Research Site

    Mueang Chanthaburi, 22000
    Thailand

    Site Not Available

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Research Site

    Leicester 2644668, LE1 5WW
    United Kingdom

    Site Not Available

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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