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

NCT00796549 | Completed Phase 2 Results

• 2 other identifiers: 1200.402008-001264-37
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 13

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Best Objective Response

  Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.

  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.

Secondary Outcomes (10)

• 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.

• 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.

• Percentage of Participants With Disease Control (DC)

  Every 8 weeks until last response assessment 28NOV12

• Duration of Confirmed Disease Control

  Every 8 weeks until last response assessment 28NOV12

• Progression Free Survival (PFS) Time

  Every 8 weeks until last response assessment 28NOV12

Study Arms (1)

BIBW 2992

EXPERIMENTAL

BIBW 2992 in EGFR FISH positive NSCLC patients

Drug: BiBW 2992

Interventions

BiBW 2992 DRUG

BIBW 2992 in EGFR FISH positive NSCLC patients

BIBW 2992

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged \>18 years.
• Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with pleural effusion) or Stage IV and histopathological classification of adeno- or bronchoalveolar carcinoma (BAC).
• Increased EGFR gene copy number assessed by FISH analysis. After signed informed consent, positive result to EGFR FISH determination is mandatory to proceed to other screening assessments.
• At least one tumour lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as more or same 20 mm using conventional techniques or moro or same 10 mm with spiral CT scan.
• Patients not previously exposed to chemotherapy for NSCLC (1st line patients, 40 in total; for these subjects adjuvant chemotherapy is allowed if at least 12 months elapsed since last course of treatment), or patients with relapse after one systemic treatment (2nd line patients, 30 in total; if less than 12 months elapsed since adjuvant chemotherapy, patients are 2nd line ones, as adjuvant chemotherapy must be considered a line of treatment).
• Life expectancy of at least three (3) months.
• Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0, 1 or 2.
• Written informed consent that is consistent with ICH-GCP guidelines.

You may not qualify if:

• More than two (2) prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic NSCLC, included adjuvant chemotherapy if relapse occurred less than 12 months before
• Previous treatment with erlotinib (Tarceva®), gefitinib (Iressa®) or any other EGFR inhibiting small molecule or antibody.
• Active brain metastases (stable \<4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
• Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
• Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn disease, malabsorption, or CTCAE Grade \>2 diarrhea of any etiology at baseline
• Patients who have any other life-threatening illness or organ system dysfunction which, in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
• Other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer and in situ cervical cancer).
• Radiotherapy within the past 2 weeks prior to treatment with the trial drug.
• Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents).
• Patients with known HIV, active hepatitis B or active hepatitis C.
• Known or suspected active drug or alcohol abuse.
• Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial.
• Pregnancy or breast feeding.
• Patients unable to comply with the protocol.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

1200.40.39011 Boehringer Ingelheim Investigational Site

Arezzo, Italy

Location

1200.40.39007 Boehringer Ingelheim Investigational Site

Aviano (PN), Italy

Location

1200.40.39013 Boehringer Ingelheim Investigational Site

Faenza (RA), Italy

Location

1200.40.39003 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1200.40.39010 Boehringer Ingelheim Investigational Site

Livorno, Italy

Location

1200.40.39012 Boehringer Ingelheim Investigational Site

Lugo (RA), Italy

Location

1200.40.39008 Boehringer Ingelheim Investigational Site

Modena, Italy

Location

1200.40.39005 Boehringer Ingelheim Investigational Site

Monza (MI), Italy

Location

1200.40.39006 Boehringer Ingelheim Investigational Site

Padua, Italy

Location

1200.40.39002 Boehringer Ingelheim Investigational Site

Perugia, Italy

Location

1200.40.39004 Boehringer Ingelheim Investigational Site

Prato, Italy

Location

1200.40.39009 Boehringer Ingelheim Investigational Site

Ravenna, Italy

Location

1200.40.39001 Boehringer Ingelheim Investigational Site

Rozzano (MI), Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Last Updated: July 22, 2014
• Results First Posted: October 17, 2013

Record last verified: 2014-07

Locations

IT (13)