Clinical trial · Interventional
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD2936 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)
- description
- Rilvegostomig Intravenous (IV) monotherapy
- interventionNames
- Drug: AZD2936
- type
- EXPERIMENTAL
- label
- Dose Expansion Part B: CPI experienced NSCLC
- description
- Rilvegostomig IV monotherapy
- interventionNames
- Drug: AZD2936
- type
- EXPERIMENTAL
- label
- Dose Expansion Part C: CPI Naive NSCLC
- description
- Rilvegostomig IV monotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available