Lung Cancer Clinical Trial

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

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.

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Full Description

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of AZD2936 in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-D (dose expansion).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

147

Study ID:

NCT04995523

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 29 Locations for this study

See Locations Near You

Research Site
Orange California, 92868, United States
Research Site
Chicago Illinois, 60637, United States
Research Site
Baltimore Maryland, 21201, United States
Research Site
Rochester Minnesota, 55905, United States
Research Site
Houston Texas, 77030, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Melbourne , 3000, Australia
Research Site
Anderlecht , 1070, Belgium
Research Site
Leuven , 3000, Belgium
Research Site
Porto Alegre , 90035, Brazil
Research Site
Sao Paulo , 01246, Brazil
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Chengdu , 61004, China
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Copenhagen , 2100, Denmark
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Dijon , 21079, France
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Toulouse Cedex 09 , 31059, France
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Kashiwa , 227-8, Japan
Research Site
Tokyo , 104-0, Japan
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Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Groningen , 9713 , Netherlands
Research Site
Leiden , 2333 , Netherlands
Research Site
Utrecht , 3584 , Netherlands
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Barcelona , 08035, Spain
Research Site
Madrid , 28027, Spain
Research Site
Madrid , 28041, Spain
Research Site
Taichung , 40201, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Leicester , LE1 5, United Kingdom
Research Site
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

147

Study ID:

NCT04995523

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

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