BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 14, 2009
End Date:March 16, 2017

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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

This randomised, open label phase III trial will be performed in patients with adenocarcinoma
of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation.
The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A,
with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of
patients.


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 International Conference on
Harmonisation-Good Clinical Practice 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.
We found this trial at
8
sites
1259 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
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Allentown, PA
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Bahía Blanca,
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Corpus Christi, TX
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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Marrero, Louisiana 70072
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Marrero, LA
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Miami, FL
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Montebello, California 90640
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Montebello, CA
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211 White Spruce Boulevard
Rochester, New York 14623
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Rochester, NY
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