BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BiBW 2992

• Registration Number: NCT00796549
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:

* Forty (40) 1st line patients

* Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.

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 First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2008-12
• Primary Completion: 2012-05
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-17
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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
BIBW 2992	BiBW 2992	BIBW 2992 in EGFR FISH positive NSCLC patients

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Best Objective Response	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.	Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.

Secondary Outcome Measures

Name	Time	Method
Duration of Confirmed Objective Response (OR)	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.	Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).
Duration of Confirmed Disease Control	Every 8 weeks until last response assessment 28NOV12	Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)	Day 15	Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
Number of Participants With Objective Response (OR) Categorized by Time	Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.	Cumulative number of participants with objective response by time points with responders.
Percentage of Participants With Disease Control (DC)	Every 8 weeks until last response assessment 28NOV12	Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.
Overall Survival (OS) Time	Baseline until last vital status assessment 17JUN13	Overall survival time is defined as time from the date of start of treatment to the date of death.
Progression Free Survival (PFS) Time	Every 8 weeks until last response assessment 28NOV12	Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder	First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks	The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 \[R04-0474\], including skin reactions and gastrointestinal AEs.
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status	End Of Treatment, up until 190 weeks	Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below : 0 : Fully active, able to carry on all pre-disease performance without restriction.; 1. : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.; 2. : Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.; 3. : Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.; 4. : Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.; 5. : Dead.; Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs\>2 are included.
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction	First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks	Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.; There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF).

Trial Locations

Locations (13)

1200.40.39008 Boehringer Ingelheim Investigational Site; 🇮🇹 Modena, Italy

1200.40.39005 Boehringer Ingelheim Investigational Site; 🇮🇹 Monza (MI), Italy

1200.40.39011 Boehringer Ingelheim Investigational Site; 🇮🇹 Arezzo, Italy

1200.40.39007 Boehringer Ingelheim Investigational Site; 🇮🇹 Aviano (PN), Italy

1200.40.39012 Boehringer Ingelheim Investigational Site; 🇮🇹 Lugo (RA), Italy

1200.40.39013 Boehringer Ingelheim Investigational Site; 🇮🇹 Faenza (RA), Italy

1200.40.39010 Boehringer Ingelheim Investigational Site; 🇮🇹 Livorno, Italy

1200.40.39003 Boehringer Ingelheim Investigational Site; 🇮🇹 Genova, Italy

1200.40.39006 Boehringer Ingelheim Investigational Site; 🇮🇹 Padova, Italy

1200.40.39002 Boehringer Ingelheim Investigational Site; 🇮🇹 Perugia, Italy

1200.40.39004 Boehringer Ingelheim Investigational Site; 🇮🇹 Prato, Italy

1200.40.39001 Boehringer Ingelheim Investigational Site; 🇮🇹 Rozzano (MI), Italy

1200.40.39009 Boehringer Ingelheim Investigational Site; 🇮🇹 Ravenna, Italy