First-line afatinib for elderly patients
- Conditions
- patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutat
- Registration Number
- JPRN-jRCTs031180136
- Lead Sponsor
- Gemma Akihiko
- Brief Summary
First-line afatinib administered as a starting dose of 40 mg was well tolerated with dose adjustments and was associated with encouraging activity in Japanese patients aged 75 years or older with EGFR mutation-positive NSCLC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 38
1. Histologically or cytological confirmed stage III/IV non-small cell lung cancer
2. Patients having EGFR mutation (exon 19 deletion or L858R)
3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies.
4. Measurable lesion for RECIST(ver 1.1)
5. Patients aged 75 years or older
6. ECOG performance status 0 to1
7. Adequate organ function
8. Life expectancy more than three months
9. Written informed consent
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 <br>Time to Treatment Failure <br>Overall Survival <br>Disease Control Rate <br>1 and 2 Year Survival Rate <br>Adverse Event