A randomized Phase II study of Carboplatin + Pemetrexed followed by Pemetrexed versus Carboplatin+Pemetrexed followed by Erlotinib in patients with advanced Non-squamous and Non- Small Cell Lung Cancer without EGFR mutations
Phase 2
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000011126
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1) Active severe comorbidity disease. 2) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 3) Patients with symptomatic Brain metastases. 4) Active concomitant malignancy. 5) History of grave drug allergic reaction. 6) Pregnant or breast-feeding females. 7) Unstable psychic disorder. 8) Accepted continuous use of steroid. 9) Administration of folic acid and vitamin B12 is not received. 10) Diagnosed EML4-ALK fusion gene positive. 11) Inappropriate patients for this study judged by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Safety Biomarker analysis Objective Response Rate