A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
- Conditions
- Stage IIIA-N2 EGFR mutated, Non-small cell lung cancer
- Registration Number
- JPRN-UMIN000026197
- Lead Sponsor
- Advanced Clinical Trial chest surgery Group (ACTG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Not provided
(1) EGFR mutation T790M postive (2) Interstitial pneumonia or pulmanary fibrosis detectable on chest CT scan (3) Privious history of drug induced lung injury (4) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.) (5) Aactive infection (6) History of congestive heart failure, angina pectoris or myocardial infarction withinthe last 1 year. (7) Unterated bone fracture or serious wound (8) Severe diarrhea (9) Current or previous (within the last 1 year) history of GI perforation or diverticultis (10) Ireus (11) Severe drug allergy (12) Investigational new drug or the unapproved drug is administered (13) History of active double cancer (14) History of pregnancy or lactation (15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression-free survival
- Secondary Outcome Measures
Name Time Method 5-year progression-free survival 2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan