Skip to main content
Clinical Trials/NCT01953913
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
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (33)

Loading locations...

Similar Trials

Afatinib (BIBW 2992) in Advanced Non-Small... | Clinical Trial