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

Tyrosine Kinase Inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with EGFR-TKI, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining PLB1004 with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In recent years, clinical studies on the combination of EGFR-TKI and chemotherapy have made important progress, suggesting that the combination of EGFR-TKI and chemotherapy further enhances the therapeutic benefit in EGFR-mutant positive NSCLC. Both preclinical and clinical data indicate that PLB1004 exhibit good antitumor activity and relatively durable efficacy in NSCLC patients with EGFR mutations. They can reduce tumor burden, control tumor progression, and improve the survival benefit of patients, which is expected to provide an effective treatment option for such patients.

NCT Number	NCT07063329
Lead Sponsor	Avistone Pharmaceutical（Ningbo）Co., LTD.
Conditions	NSCLC (Non-small Cell Lung Cancer)
Enrollment	108 participants
Start Date	2025-08-08
Primary Completion	2028-03-08 (estimated)
Study Completion	2028-07-08 (estimated)
Updated on ClinicalTrials.gov	2025-07-25