Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations.
- Conditions
- 1) Stage IIIB, IV or relapsed non-squamous cell carcinoma in non-small cell lung cancer 2) Harboring sensitive EGFR mutations 3) After progress disease of 1st line treatment by gefitinib or erlotinib
- Registration Number
- JPRN-UMIN000015582
- Lead Sponsor
- orth East Japan Study Group (NEJSG)
- Brief Summary
Maximum tolerated dose (MTD) was Level 1: afatinib 20mg/day with carboplatin AUC 5 and pemetrexed 500mg/m2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1)Having problematic interstitial lung disease or lung fibrosis on chest CT 2)Having prior treatment(s) by afatinib and/or pemetrexed 3)Having persistent Grade >=2 non-hematological toxicity by gefitinib or erlotinib 4)Having uncontrollable pleural and/or peritoneal effusion 5)Having symptomatic brain metastasis 6)After radiotherapy for primary lesion 7)Having problematic complication(s) 8)Having infectious disease to be treated 9)Having active, double cancer 10)Having sever malabsorption syndrome 11)Pregnant women, or having possibility of pregnancy; man having no intent to birth control 12)Having psychological disorder 13)In addition, the primary doctor judging inappropriate for entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD, Dose Limiting Toxicity (DLT), Recomennded Dose (RD)
- Secondary Outcome Measures
Name Time Method