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.

Inclusion Criteria: * 1\. 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 previous systemic treatment. Specific treatment requirements are as follows: * Patients with EGFR sensitive mutations: They must have received EGFR-TKI treatment. If only first/second-generation EGFR-TKIs were used, T790M negativity must be confirmed. * Patients with other EGFR mutations such as EGFR exon 20 insertion: They must have received platinum-based chemotherapy. Phase Ib Dose-expansion part and Cohort 1 of Phase II: Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment or have received systemic treatment. Cohort 2 of Phase II: Patients with histologically confirmed resectable stage II-III NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment; among them, N2 is defined as single-station mediastinal lymph node non-bulky metastasis (lymph node short diameter \