Efficacy and safety of first-line gefitinib treatment in metastatic lung adenocarcinoma patients with sensitizing EGFR mutation determined by ddPCR in plasma cell-free DNA (BENEFIT trial)

Background

This study is to evaluate efficacy and safety of first-line gefitinib treatment in metastatic lung adenocarcinoma patients with sensitizing EGFR mutation determined by digital PCR (ddPCR) in plasma cell-free DNA (cf-DNA)

Trial design

Adenocarcinoma NSCLC patients (stage IV, PS 0-2, available tumor tissue) with EGFR mutation detected by ddPCR in plasma will accept gefitinib treatment until PD. Primary endpoint is ORR. Secondary endpoints are PFS, DCR, QOL, and the concordance, sensitivity, specificity of EGFR mutation between ddPCR in plasma DNA and ARMS in tissue. EGFR mutation status in cf-DNA will be dynamically monitored every 8 weeks. A sample size of 159 will provide a precision of 7% (95% CI: 65%, 79%) assuming 72% ORR, 177 patients should be enrolled with 10% drop-off rate. By Dec 25th, 2015, 426 patients were screened using ddPCR in plasma, 188 patients were enrolled, and last patient last visit will be at October 2016. (NCT02282267).

Clinical trial identification

NCT02282267

Legal entity responsible for the study

N/A

Funding

AstraZeneca R&D

Disclosure

All authors have declared no conflicts of interest.