Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Phase 4

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung; ErbB Receptors
• Interventions: Drug: Afatinib

• Registration Number: NCT02695290
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-01
• Study Start: 2016-03-17
• Primary Completion: 2016-08-26
• Study Completion: 2016-08-26
• Results First Submitted: 2017-08-09
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Results First Posted: 2017-09-18
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib	Afatinib	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib	Up to 98 days	Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)	Up to 98 days	Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).
Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)	Up to 98 days	Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.

Trial Locations

Locations (1)

1200.208.10032 Boehringer Ingelheim Investigational Site; 🇺🇸 Fountain Valley, California, United States