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Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Phase 3
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AfatinibAfatinibPatient will receive afatinib once daily
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 EventsFrom 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

Scroll for more (23 remaining)
307 Hospital of PLA
🇨🇳Beijing, China

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