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First received: September 06, 2023

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

Study Status: ACTIVE_NOT_RECRUITING

Recruit Status: ACTIVE_NOT_RECRUITING

Condition: Non-Small Cell Lung Cancer

Study Type: INTERVENTIONAL


Official Title: A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

Brief Summary: 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.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…

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