Lung Cancer Clinical Trial
Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer
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.
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).
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
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.
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There are 29 Locations for this study
Orange California, 92868, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Rochester Minnesota, 55905, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Melbourne , 3000, Australia
Anderlecht , 1070, Belgium
Leuven , 3000, Belgium
Porto Alegre , 90035, Brazil
Sao Paulo , 01246, Brazil
Chengdu , 61004, China
Copenhagen , 2100, Denmark
Dijon , 21079, France
Toulouse Cedex 09 , 31059, France
Kashiwa , 227-8, Japan
Tokyo , 104-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Groningen , 9713 , Netherlands
Leiden , 2333 , Netherlands
Utrecht , 3584 , Netherlands
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Taichung , 40201, Taiwan
Taipei , 10002, Taiwan
Leicester , LE1 5, United Kingdom
Manchester , M20 4, United Kingdom
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