Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive is a phase 1/2, interventional study registered as NCT07063329 by Avistone Pharmaceutical（Ningbo）Co., LTD., with a registry enrolment figure of 108 participants, started 2025-08-08 and due to reach its primary completion in 2028-03-08. Interventions recorded: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy; RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy. Conditions listed: NSCLC (Non-small Cell Lung Cancer). Primary outcome: Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]); Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol; Phase Ib： Recommended Phase II Dose (RP2D). Lung eligibility wording from the registry: "Phase Ib Dose-escalation Part : Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of the AJCC lung cancer staging criteria) who have disease progression or intolerance after prev". Sites: China. No results are recorded here; the registry entry is the source.