Phase II study of Durvalumab (MEDI4736) Plus Concurrent Radiation Therapy in Advanced Localized NSCLC Patients(Dolphin study: WJOG11619L)
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-jRCT2080224763
- Lead Sponsor
- Motoko Tachihara (Coordinating Investigator)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 35
(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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression free survival rate at 12 months
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Progression free survival, progression free survival rate at 18 months, overall survival, treatment completion rate, duration of response, response rate, disease control rate, duration to death or metastasis, safety and difference of efficacy in patient background/PD-L1 expression.