First-line afatinib for elderly patients

JRCT ID: jRCTs031180136

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutat
• Date of first enrollment: 28/01/2016
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Afatinib 40mg/body daily oral administration

Outcome(s)

• Primary Outcome: Overall Response Rate

Secondary Outcome

Progression Free Survival
Time to Treatment Failure
Overall Survival
Disease Control Rate
1 and 2 Year Survival Rate
Adverse Event

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Gemma Akihiko
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co ., Ltd.
• Secondary ID(s): UMIN000017877