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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

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

Treatments: Drug: BIBW 2992; Drug: Pemetrexed; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949650

1200.32

2008-005615-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 2 patient groups

BIBW 2992

Experimental group

Description:

BIBW 2992 tablet once daily until progression

Treatment:

Drug: BIBW 2992

Cisplatin/Pemetrexed

Active Comparator group

Description:

Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles

Treatment:

Drug: Pemetrexed

Drug: Cisplatin