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 cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000857-23-DK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
- 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.
- 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
- Adequate bone marrow, liver and kidney function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96
- 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 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.
- 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