Lung Cancer Clinical Trial

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

Summary

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

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Full Description

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).

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Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

105

Study ID:

NCT03509012

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 16 Locations for this study

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Research Site
Tucson Arizona, 85719, United States
Research Site
Aurora Colorado, 80045, United States
Research Site
Houston Texas, 77090, United States
Research Site
Koto-ku , 135-8, Japan
Research Site
Sunto-gun , 411-8, Japan
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Seoul , 13620, Korea, Republic of
Research Site
Badalona , 08916, Spain
Research Site
Madrid , 28007, Spain
Research Site
Málaga , 29010, Spain
Research Site
Taichung , 40705, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 112, Taiwan
Research Site
Taoyuan City , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

105

Study ID:

NCT03509012

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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