Abstract
Dacomitinib is a second-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). ARCHER-1050 suggested that dacomitinib can prolong progression-free survival (PFS) and overall survival (OS) in advanced non-small cell lung cancer patients with 19del or 21L858R compared to standard first-generation EGFR-TKI. However, it is still unclear whether this agent is effective in patients with uncommon EGFR mutations in exon 18-21. This is a single arm, prospective, open label and phase II trial. A total of 30 eligible patients will be recruited. Patients will receive continuous oral therapy with the study drugs (dacomitinib 45 mg) until disease progression, withdrawal of consent, or unacceptable toxicity. The primary endpoint is objective response rate (ORR) per RECIST version 1.1, as determined by investigators’ review. The second endpoint is disease control rate (DCR), PFS, OS, and safety. The primary endpoint of the study is ORR as determined by investigators’ review. Sample size will be calculated by a minimax two-stage design method based on the following parameters: α=0.075, 1-β=0.9, P0=0.20, P1=0.45. The optimal two-stage design tests the null hypothesis that P ≤ 0.20 versus the alternative that P ≥ 0.45. After testing the drug on 12 patients in the first stage, the trial will be terminated if 2 or fewer patients respond. If the trial goes on to the second stage, a total of 27 patients will be studied. If the total number responding is less than or equal to 8, the drug is considered noneffective. Assuming a dropout rate of 10%, 30 patients will be finally enrolled. The study has been registered in clinicaltrial.gov and the registration number is NCT04504071. The study will recruit participants in September 2020 and is expected to take 26 months. We conduct a phase II study to investigate the safety and efficacy of dacomitinib in advanced NSCLC patients with uncommon EGFR mutations.
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