Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
- Registration Number
- NCT01953913
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 542
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Afatinib Afatinib Patient will receive afatinib once daily
- Primary Outcome Measures
Name Time Method Percentage of Participants With Serious Adverse Events (SAEs) From first drug administration up to 28 days after last drug administration, up to 1624 days. Percentage of participants with serious adverse events (SAEs).
- Secondary Outcome Measures
Name Time Method Time to Symptomatic Progression (TTSP) From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days. Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
Percentage of Participants With Drug-related (Afatinib-related) Adverse Events From first drug administration up to 28 days after last drug administration, up to 1624 days. Percentage of participants with drug-related (afatinib-related) adverse events.
Trial Locations
- Locations (33)
307 Hospital of PLA
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Jilin Province Cancer Hospital
🇨🇳Changchun, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Lin Yi Tumor Hospital
🇨🇳Linyi, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
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