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Evaluating a new bispecific antibody for advanced lung cancer

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Phase1; Phase2 Interventional AstraZeneca · NCT04995523

This study is testing a new antibody treatment for adults with advanced lung cancer to see how safe it is and if it helps improve their condition.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment199 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations48 sites (Orange, California and 47 other locations)
Trial IDNCT04995523 on ClinicalTrials.gov

What this trial studies

This Phase I/II study aims to assess the safety, tolerability, and efficacy of the experimental bispecific antibody rilvegostomig (AZD2936) in adults with advanced or metastatic non-small cell lung cancer (NSCLC). The study is open-label and multicenter, consisting of dose-escalation and dose-expansion phases to determine the optimal dosing and therapeutic effects. Participants will be monitored for pharmacokinetics and pharmacodynamics, as well as overall treatment outcomes. The study includes various parts targeting different stages of NSCLC and treatment histories.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with unresectable stage III or IV NSCLC who have documented PD-L1 expression and meet specific inclusion criteria.

Not a fit: Patients with sensitizing EGFR mutations or ALK fusions, as well as those who have received prior immunotherapy for metastatic NSCLC, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced or metastatic NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies exploring bispecific antibodies and immune checkpoint inhibitors have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Orange, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small-Cell Lung CarcinomaTIGIT, Anti-TIGITPD-1, Anti-PD-1NSCLC, Non-small Cell Lung CancerAdvanced, Metastatic, Solid Tumor, Solid TumourStage 3 NSCLC, Stage III NSCLCStage 4 NSCLC, Stage IV NSCLCPD L1+ tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.