A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.

NCT Number	NCT06046495
Lead Sponsor	Avistone Biotechnology Co., Ltd.
Conditions	Non-Small Cell Lung Cancer
Enrollment	81 participants
Start Date	2024-07-08
Primary Completion	2028-02-09 (estimated)
Study Completion	2028-02-09 (estimated)
Updated on ClinicalTrials.gov	2025-04-23