A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer
- Conditions
- Advanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, stage III unresectable Non-small Cell Lung Cancer (Protocol Parts A-B), stage IV Non-small Cell Lung Cancer (Protocol Parts A-D)MedDRA version: 20.1Level: LLTClassification code: 10080083Term: Advanced lung cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508262-15-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
Written informed consent, Adequate bone marrow, liver and kidney function, Aged 18 or above, Part A and Part B: Unresectable stage III or stage IV squamous or nonsquamous 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., Documented PD-L1 expression by PD-L1 IHC per local report, Confirmed progression during treatment with a CPI-including regimen (Part A, Part B), No prior IO treatment for metastatic NSCLC (Part C, Part D), 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
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 regimens including a CPI, Part C and Part D: Any prior systemic treatment with an immuneoncology 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., 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method