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.
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).
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 43 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
Florianópolis , 88034, Brazil
Porto Alegre , 90035, Brazil
Rio de Janeiro , 20231, Brazil
Sao Paulo , 01246, Brazil
Chengdu , 61004, China
Chongqing , 40003, China
Wuhan , 43002, China
Copenhagen , 2100, Denmark
Dijon , 21079, France
Toulouse Cedex 09 , 31059, France
Kashiwa , 227-8, Japan
Niigata-shi , 951-8, Japan
Sendai-shi , 980-0, Japan
Tokyo , 104-0, Japan
Seoul , 03082, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Kuala Lumpur , 59100, Malaysia
Kuching , 93586, Malaysia
Groningen , 9713 , Netherlands
Leiden , 2333 , Netherlands
Utrecht , 3584 , Netherlands
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Taichung , 40201, Taiwan
Taichung , , Taiwan
Tainan City , 70403, Taiwan
Taipei City , 110, Taiwan
Taipei , 10002, Taiwan
Bangkok , 10700, Thailand
Muang , 50200, Thailand
Mueang Chanthaburi , 22000, Thailand
Leicester , LE1 5, United Kingdom
Manchester , M20 4, United Kingdom
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.