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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 28, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT07063329). This is a study registration, not published results. Lead sponsor: Avistone Pharmaceutical（Ningbo）Co., LTD.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 108 participants (ESTIMATED). Conditions: NSCLC (Non-small Cell Lung Cancer). Interventions: DRUG: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; DRUG: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy; DRUG: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy; DRUG: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy. Primary outcome measures: Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) , 12 months; Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol , 12 months; Phase Ib： Recommended Phase II Dose (RP2D) , 12 months; Phase Ib： Overall Response Rate (ORR） , 24 months; Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D in subjects with EGFR mutation positive locally advanced or metastatic NSCLC , 36 months; Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D RP2D in newly diagnosed resectable stage II-III NSCLC subjects with EGFR mutation positive , 12 months. Brief summary: 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.