Japanese Phase I/II open-label trial of continuous once daily oral treatment with afatinib – Phase I trial in advanced non-small cell lung cancer (NSCLC) patients & Phase II trial in NSCLC patients after failure of erlotinib or gefitinib.
LUX-Lung 4 – Afatinib* Phase I Trial in Advanced Non-Small Cell Lung Cancer Patients & Phase II Trial in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib
Pathologically confirmed diagnosis of NSCLC
Failure of conventional treatment or no therapy of proven efficacy
Eastern Cooperative Oncology Group performance status
Progressed after 1 or 2 lines of chemotherapy (incl. 1
Phase I: afatinib
Oral once daily finding maximum tolerated dose up to 50 mg/day
Phase II: afatinib
Oral once daily, continuous treatment at high dose
Phase I Primary Outcome Measures:
Safety of afatinib – incidence of dose limiting toxicity and incidence & intensity of adverse events (AEs)
Phase I Secondary Outcome Measures:
Pharmacokinetics of afatinib after multiple oral administration
Summary of Epidermal Growth Factor Receptor (EGFR) mutations
Phase II Primary Outcome Measures:
Objective response rate
Phase II Secondary Outcome Measures:
Disease control rate
Time to and duration of objective
Duration of disease control
Overall survival (OS)
Summary of EGFR mutations
Of 62 evaluable patients in the Phase II trial, five had a confirmed OR to afatinib (8.2%; 95% CI
The most common
Afatinib showed activity in patients with NSCLC who had received third- or fourth-line treatment and who had disease progression while receiving erlotinib and/or gefitinib.
Katakami N, Atagi S, Goto K, et al.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT00711594 (Accessed: May 2016).