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

Last updated: April 15, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

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: 199
Treatment Group(s): 1
Primary Treatment: AZD2936
Phase: 1/2
Study Start date:
September 14, 2021
Estimated Completion Date:
March 16, 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

    Completed

  • Research Site

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • Research Site

    Bruxelles, 1000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Research Site

    Florianópolis, 88034-000
    Brazil

    Active - Recruiting

  • Research Site

    Natal, 59075-740
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Research Site

    Chengdu, 610041
    China

    Active - Recruiting

  • Research Site

    Chongqing, 400030
    China

    Active - Recruiting

  • Research Site

    Wuhan, 430022
    China

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Research Site

    Dijon, 21079
    France

    Active - Recruiting

  • Research Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Research Site

    Toulouse Cedex 09, 31059
    France

    Site Not Available

  • Research Site

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Research Site

    Kashiwa, 227-8577
    Japan

    Active - Recruiting

  • Research Site

    Niigata-shi, 951-8566
    Japan

    Active - Recruiting

  • Research Site

    Sendai-shi, 981-0914
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

  • Research Site

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Research Site

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Research Site

    Utrecht, 3584 CX
    Netherlands

    Completed

  • Research Site

    Singapore, 308433
    Singapore

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Taichung, 40201
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 110
    Taiwan

    Active - Recruiting

  • Research Site

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Research Site

    Muang, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Mueang Chanthaburi, 22000
    Thailand

    Active - Recruiting

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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