A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: afatinib (BIBW 2992)

• Registration Number: NCT01003899
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2011-11
• Status Verified: 2013-08
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-17
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
afatinib (BIBW 2992)	afatinib (BIBW 2992)	patient to receive afatinib(BIBW 2992) po QD in an open-label manner

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Best Objective Response	Baseline till progression or death	Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Disease Control (DC)	Baseline till progression or death	Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.
Time to OR	Baseline till progression or death	The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.
Progression Free Survival (PFS) Time	Baseline till end of study or death	PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death
Duration of Disease Control (DC)	Baseline till progression or death	Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).
Duration of OR	Baseline till progression or death	Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

Trial Locations

Locations (3)

1200.72.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1200.72.8203 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1200.72.8202 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of