Phase II study of immunotherapy and cytotoxic agent in combination with palliative radiotherapy in patients with advanced non-small cell lung cancer
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000036856
- Lead Sponsor
- Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 38
Not provided
1)Presence of EGFR mutation, ALK fusion gene, ROS1 fusion gene or BRAF mutation 2)Prior immunotherapy or radiotherapy 3)Symptomatic brain metastases 4)Patient with autoimmune disease 5)Patient with history of organ transplantation 6)Severe complication (uncontrolled heart failure, renal failure, chronic liver failure, diabetes mellitus, intestinal obstruction, active gastrointestinal ulceration, etc.) 7)Positive for hepatitis B surface (HBs) antigen or detectable HB virus DNA with positive for HBs antibody or hepatitis B core antibody 8)Radiographically confirmed interstitial pneumonitis 9)Receiving continuous systemic corticosteroid or immunosuppressant treatment or within 2 weeks after discontinuation 10)Pleural effusion, ascites or pericardial effusion requiring drainage 11)Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy 12)Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 13)History of severe drug allergies 14)Other ineligible status judged by attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year progression-free survival rate
- Secondary Outcome Measures
Name Time Method Response rate, Disease control rate, Progression-free survival, Overall survival, Safety