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A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

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Trial Information

A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

Inclusion Criteria


Inclusion criteria:

- Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural
effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients
with mixed histology are eligible if adenocarcinoma is the predominant histology.

- Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of
tumour biopsy material.

- Measurable disease according to RECIST 1.1.

- Eastern Cooperative Oncology Group score of 0 or 1.

- Age >/= 18 years.

- Life expectancy of at least three months.

- Written informed consent that is consistent with ICH-GCP guidelines.

Exclusion criteria:

- Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant
chemotherapy is permitted if at least 12 months has elapsed between the end of
chemotherapy and randomisation.

- Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or
antibodies.

- Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.

- Active brain metastases

- Any other current malignancy or malignancy diagnosed within the past five years

- Known pre-existing interstitial lung disease.

- Significant or recent acute gastrointestinal disorders with diarrhoea as a major
symptom.

- History or presence of clinically relevant cardiovascular abnormalities.

- Any other concomitant serious illness or organ system dysfunction.

- Adequate absolute neutrophil count and platelet count

- Adequate liver and kidney function

- Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint will be progression free survival, as determined by RECIST 1.1.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica

Study ID:

1200.32

NCT ID:

NCT00949650

Start Date:

August 2009

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

1200.32.2605 Boehringer Ingelheim Investigational SiteFayetteville, Arkansas  
1200.32.2617 Boehringer Ingelheim Investigational SiteMontebello, California  
1200.32.2616 Boehringer Ingelheim Investigational SiteMiami, Florida  
1200.32.2606 Boehringer Ingelheim Investigational SiteMarrero, Louisiana  
1200.32.2603 Boehringer Ingelheim Investigational SiteRochester, New York  
1200.32.2608 Boehringer Ingelheim Investigational SiteAllentown, Pennsylvania  
1200.32.2609 Boehringer Ingelheim Investigational SiteCorpus Christie, Texas