Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation EGFR-TKI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Afatinib; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy

• Adequate hematological function (ANC >=1.5 x 10^9/l, Hb >=9.0 x 10^9/l, plt >=100 x 10^9/l)

• Adequate renal function (with estimated creatinine clearance >=50ml/min as determined by Cockcroft-Gault formula)

• Adequate liver function (ALT/AST <2.5 x upper normal limit or ALT/AST <5 x upper normal limit in the presence of liver metastasis)

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Evaluable target lesions according to RECIST 1.1 for tumour response assessment

• Patients able to give written consent

Exclusion Criteria:

• Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication

• Significant cardiovascular abnormalities

• Significant psychiatric disorders

• Patients who have documented history of interstitial lung disease