First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
- Conditions
- patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations
- Registration Number
- JPRN-UMIN000017877
- Lead Sponsor
- on Profit Organization North East Japan Study Group
- Brief Summary
Patients characteristics N=38 (SAS) Gender:Male/Female 12/23 Age:median(range) 77 (75-91) years Smoking status:Never 26(68.4%) ECOG PS:0/1 21/17 EGFR mutation type:ex19del/L858R 23/15 Promary endpoint Objective response rate:75.7% (95%CI 58.8-88.2%) Secondary endpoint Disease control rate:33% (74.6-97.0%) Adverse event: All garade 100%, grade3/4 63.2% Grade5 0%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Not provided
1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment 2. Previous radiotherapy to the primary tumor or mesurable lesion 3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis 5. Massive pleural or pericardial effusion, or ascites 6. Symptomatic brain metastases 7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug 8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier. 9. Other concurrent active malignancy 10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug 11. Pregnancy 12. Clinically significant phycological problem 13. Patients with uncontrollable complications 14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate
- Secondary Outcome Measures
Name Time Method Progression Free Survival Time to Treatment Failure Overall Survival Disease Control Rate 1 and 2 Year Survival Rate Adverse Event