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

• Status: Completed
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib; Cisplatin; Pemetrexed

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 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.