[Translation] A single-arm, open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)
I期:
主要目的:
评价XZP-5809-TT1片在经表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)治疗后进展的T790M突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者中的安全性和耐受性。
次要目的:
评价XZP-5809-TT1片及其主要代谢产物在经表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)治疗后进展的T790M突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者中的药代动力学特征及有效性。
II期:
主要目的:
评价XZP-5809-TT1片在经EGFR-TKI治疗后进展T790M突变阳性的局部晚期或转移性NSCLC患者中的客观缓解率(ORR)。
次要目的:
评价XZP-5809-TT1片在经EGFR-TKI治疗后进展T790M突变阳性的局部晚期或转移性NSCLC患者中的有效性,安全性及药代动力学特征。
I/II期:
探索性目的:
初步探索血液ctDNA T790M突变与XZP-5809-TT1片的疗效关系以及XZP-5809-TT1的耐药机制。
[Translation] Phase I:
Primary purpose:
To evaluate the safety and tolerability of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).
Secondary purpose:
To evaluate the pharmacokinetic characteristics and efficacy of XZP-5809-TT1 tablets and its main metabolites in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).
Phase II:
Primary purpose:
To evaluate the objective response rate (ORR) of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic NSCLC who have progressed after treatment with EGFR-TKIs.
Secondary purpose:
To evaluate the efficacy, safety and pharmacokinetic characteristics of XZP-5809-TT1 tablets in patients with locally advanced or metastatic NSCLC who are positive for T790M mutation and progress after EGFR-TKI treatment.
Phase I/II:
Exploratory purpose:
To preliminarily explore the relationship between blood ctDNA T790M mutation and the efficacy of XZP-5809-TT1 tablets and the resistance mechanism of XZP-5809-TT1.