Phase II study of nivolumab for advanced non-small-cell lung cancer patients not indicative of cytotoxic chemotherapy
Phase 2
- Conditions
- advanced non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000020855
- Lead Sponsor
- Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1) The age of less than 20 2) Indicative for cytotoxic chemotherapy or molecular targeted agents 3) Uncontrolled brain metastasis treated by palliative radiotherapy 4) Clinically active infection 5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) Uncontrolled pleural effusion 7) Active other organ cancers 8) History of severe drug allergy 9) Uncontrolled digestive ulcer 10) Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, Overall survival, and Toxicity. AND, we will explore serum or blood-based biomarker analysis and immune state as the accompanying research with the informed consent