A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000003422
- Lead Sponsor
- Thoracic Oncology Research Group
- Brief Summary
A total of 10 patients with PS 0, 1, or 2 EGFR-wild type NSCLC were enrolled in phase II. In phase II, the ORR was 10.0%, and the disease control rate (DCR) was 40.0%. After the enrollment of 10 subjects, enrollment was stopped based on two treatment-related deaths.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1)no other evaluable lesion after the prior irradiation for the primary tumor 2)the superior vena caval syndrome 3)previous drug allergy 4)massive pericardial effusion, or ascites 5,8,16)serious underlying diseases(interstitial pneumonia, serious cardiac diseases, serious infection) 6,7)diarrhea to last, ileus, or intestinal tract paralysis 9)symptomatic ophthalmologic disease 10)current or previous (within the last 1 year)history of GI perforation 11)serious non-healing ulcer 12)symptomatic or steroid-requiring brain metastases 13,14)active concomitant malignancy 15)uncontrolled diabetes mellitus 17)severe psychological disease 18)hoped to be pregnant/nursing 19)those judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method