A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000015949
- Lead Sponsor
- PO Thoracic Oncology Research Group
- Brief Summary
An independent review committee confirmed a significant ORR of 60.0%(90% CI, 50.2%-69.2%). The disease control rate was 90.0%(90% CI, 82.7%-94.9%), median progression-free survival was 9.3 months (95%CI, 7.2-11.4 months), and median overall survival was 26.2 months (95%CI, 21.9-30.4 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) prior EGFR-TKI 2) active concomitant malignancy 3) concomitant brain metastasis require radiotherapy 4) interstitial pneumonia or lung fibrosis evident on CT 5) symptomatic ophthalmologic disease 6) patients having clinically important ophthalmic disorder 7) patients having clinically important neuropsychiatric disorder 8) pregnant or lactating women or those who declined contraception 9) patients judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method -Disease Control Rate -Response Rate containing SD patients after dose escalation -Safety -Progression Free Survival -Overall Survival