JPRN-jRCT2080224763
Completed
Phase 2
Phase II study of Durvalumab (MEDI4736) Plus Concurrent Radiation Therapy in Advanced Localized NSCLC Patients (Dolphin study: WJOG11619L Investigator-Initiated Clinical Trial)
Motoko Tachihara (Coordinating Investigator)0 sites35 target enrollmentJuly 3, 2019
Conditionsnon-small-cell lung cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- non-small-cell lung cancer
- Sponsor
- Motoko Tachihara (Coordinating Investigator)
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(Inclusion criteria for 1st registration)
- •1\.Patients with a histologically confirmed diagnosis of NSCLC
- •2\.Patients with measurable disease as defined by the RECIST version 1\.1
- •3\.Patients who were not previously treated with chemotherapy for ling cancer
- •4\.ECOG PS 0 or 1
- •(Inclusion criteria for 2nd registration)
- •1\.PD\-L1 expression \>\=1% (SP263\)
- •2\.Patients who are confirmed to be stage IIIA/IIIB/IIIC clinically according to General Rule for Clinical and Pathological Record of Ling cancer (the 8th edition)
- •3\.Possible to start radiation therapy based on the protocol in this study.
Exclusion Criteria
- •1\.Patients with active other cancers except for NSCLC
- •2\.Patients with a past or current history of interstitial lung disease evident on CT scans,
- •3\.Patients with a history of immune antibody therapy and other immunotherapy
- •4\.Pregnant women, lactating women, women who may be pregnant at present.
Outcomes
Primary Outcomes
Not specified
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