A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Trial end date: 2023-12-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody, AZD2936 is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Written informed consent

• Aged 18 or above

• Unresectable stage III or 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.

• ECOG performance status of 0 or 1 at enrolment.

• Life expectancy of ≥ 12 weeks at enrolment.

• 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.

• Primary or secondary resistance after treatment with 2 or more regimens including a CPI.

• Symptomatic central nervous system (CNS) metastasis.

• Thromboembolic event within 3 months prior to enrolment.

• Other invasive malignancy within 2 years prior to screening.