NCT01953913CompletedPhase 3
An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Boehringer Ingelheim33 sites in 5 countries542 target enrollmentStarted: September 30, 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 542
- Locations
- 33
- Primary Endpoint
- Percentage of Participants With Serious Adverse Events (SAEs)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Afatinib
Experimental
Patient will receive afatinib once daily
Intervention: Afatinib (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: 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 Outcomes
- 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.)
- 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.)
Investigators
Study Sites (33)
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