Randomized phase II study of continuous gefitinib plus chemotherapy versus alternation of gefitinib and chemotherapy in previously untreated non-small cell lung cancer (NSCLC) with sensitive EGFR mutations (NEJ005/TCOG0902)
Phase 2
- Conditions
- on-small cell lung cancer with EGFR mutations (non-squamous histology)
- Registration Number
- JPRN-UMIN000002789
- Lead Sponsor
- orth East Japan Study Group/The Tokyo Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Presence of active interstitial pneumonia 2) Resistant T790M mutation 3) Unstable metastases to the brain 4) History of radiotherapy for primary lesion 5) Severe and uncontrolled complication 6) Severe gastroenterological and intestinal disease 7) Treatment with steroid for longer than 4 weeks 8) Uncontrolled pleural effusion or ascites 9) Pregnant patients 10) Gefitinib contraindication 11) Other active malignancies 12) Decision of ineligibility by a physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Response rate, overall survival, and safety