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
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.
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 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 (Treatment with one previous systemic chemotherapy will be allowed).
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:

192

Study ID:

NCT04995523

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 43 Locations for this study

See Locations Near You

Research Site
Orange California, 92868, United States
Research Site
Chicago Illinois, 60637, United States
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Baltimore Maryland, 21201, United States
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Rochester Minnesota, 55905, United States
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Houston Texas, 77030, United States
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Fairfax Virginia, 22031, United States
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Melbourne , 3000, Australia
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Anderlecht , 1070, Belgium
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Leuven , 3000, Belgium
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Florianópolis , 88034, Brazil
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Porto Alegre , 90035, Brazil
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Rio de Janeiro , 20231, Brazil
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Sao Paulo , 01246, Brazil
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Chengdu , 61004, China
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Chongqing , 40003, China
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Wuhan , 43002, 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
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Niigata-shi , 951-8, Japan
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Sendai-shi , 980-0, Japan
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Tokyo , 104-0, Japan
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Seoul , 03082, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Kuala Lumpur , 59100, Malaysia
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Kuching , 93586, Malaysia
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Groningen , 9713 , Netherlands
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Leiden , 2333 , Netherlands
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Utrecht , 3584 , Netherlands
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Singapore , 30843, Singapore
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Barcelona , 08035, Spain
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Madrid , 28027, Spain
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Madrid , 28041, Spain
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Taichung , 40201, Taiwan
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Taichung , , Taiwan
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Tainan City , 70403, Taiwan
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Taipei City , 110, Taiwan
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Taipei , 10002, Taiwan
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Bangkok , 10700, Thailand
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Muang , 50200, Thailand
Research Site
Mueang Chanthaburi , 22000, Thailand
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:

192

Study ID:

NCT04995523

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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