Lung Cancer Clinical Trial
Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors
This study will initially treat up to approximately 300 patients with advanced solid tumors at approximately 30 sites, worldwide. The study will be composed of a dose-limiting toxicity (DLT) assessment phase (Part A) and an expansion phase (Part B).
World Health Organization (WHO)/ECOG performance status of 0 or 1
Body weight >30 kg at enrollment and treatment assignment
At least 1 measurable lesion, not previously irradiated
No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
For patients with oropharyngeal HNSCC HPV status has to be known
Patients with simultaneous primary malignancies or bilateral tumors
Active or prior documented autoimmune or inflammatory disorders
Brain metastases or spinal cord compression
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
Has a paraneoplastic syndrome (PNS) of autoimmune nature
HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
SCLC cohort: Extensive-stage SCLC
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There are 16 Locations for this study
Tucson Arizona, 85719, United States
Aurora Colorado, 80045, United States
Houston Texas, 77090, United States
Koto-ku , 135-8, Japan
Sunto-gun , 411-8, Japan
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 13620, Korea, Republic of
Badalona , 08916, Spain
Madrid , 28007, Spain
Málaga , 29010, Spain
Taichung , 40705, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taoyuan City , 333, Taiwan
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