Hainan Yuekang Biomedicine Co Ltd

To evaluate the effectiveness of YK-029A tablets compared with platinum-containing doublet chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations; to evaluate the safety of YK-029A tablets compared with platinum-containing doublet chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations; to evaluate the effects of YK-029A tablets compared with platinum-containing doublet chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations on disease-related symptoms and health-related quality of life.

To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of YK-029A tablets, and determine the recommended dosing regimen and dose for Phase II clinical trials. To study the pharmacokinetic characteristics of YK-029A tablets, analyze the relationship between pharmacokinetics and pharmacodynamics (PK/PD)/toxicity (PK/AE), and detect metabolites. To evaluate the preliminary efficacy of YK-029A tablets in patients with advanced non-small cell lung cancer with acquired resistance and disease progression to T790M mutation after previous epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment.