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

Completed · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00949650

Run by

Boehringer Ingelheim

People needed

345

Starts

2009-08-14

Expected to finish

2017-03-16

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trials and Research Associates Inc — Montebello, California, United States
• Innovative Medical Research of South Florida — Miami, Florida, United States
• Crescent City Research Consortiom — Marrero, Louisiana, United States
• Interlakes Foundation, Incorporated — Rochester, New York, United States
• Lehigh Valley Hospital / Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• South Texas Institute of Cancer, Northwest Cancer Center — Corpus Christi, Texas, United States
• Instituto de Medicina Nuclear de Bahía Blanca — Bahía Blanca, Argentina
• Hospital Alemán — Capital Federal, Argentina
• Imcaba S.R.L. — Capital Federal, Argentina
• IMAI Research — Capital Federal, Argentina
• Instituto Alexander Fleming — Capital Federal, Argentina
• Hospital Militar Central — Capital Federal, Argentina
• PALIAR — Capital Federal, Argentina
• Centro Oncológico de Rosario — Rosario, Argentina
• Lifehouse — Camperdown, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• The Burnside War Memorial Hospital — Toorak Gardens, South Australia, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• St. Vincents Hospital (MEL) — Fitzroy, Victoria, Australia
• Mount Medical Centre — Perth, Western Australia, Australia
• KH d. Elisabethinen Linz — Linz, Austria
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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