[Translation] A Single-Arm, Preliminary Efficacy Evaluation of AL8326 in Small Cell Lung Cancer
Open-label, non-randomized, Phase Ib/IIa study
主要目的
基于一线含铂化疗后未发生疾病进展的小细胞肺癌(SCLC)患者的无进展生存率、一线含铂化疗后复发或进展的SCLC患者的客观缓解率(ORR)、及二线及以上治疗后复发或进展的SCLC患者的ORR等指标评价AL8326单药治疗小细胞肺癌的有效性;
次要目的
评价AL8326单药在经一线含铂化疗未疾病进展的小细胞肺癌患者中的安全性及耐受性;评价AL8326单药在经一线含铂化疗后复发或进展的小细胞肺癌患者中的安全性和耐受性;评价AL8326单药在经至少二线治疗方案后复发或进展的小细胞肺癌患者中的安全性和耐受性;
探索性目的(可选)
探索AL8326对SCLC患者体内免疫细胞的影响。
[Translation] main purpose
Based on progression-free survival in patients with small cell lung cancer (SCLC) without disease progression after first-line platinum-based chemotherapy, objective response rate (ORR) in SCLC patients who relapsed or progressed after first-line platinum-based chemotherapy, and recurrence after second-line or more therapy Or the ORR and other indicators of advanced SCLC patients to evaluate the effectiveness of AL8326 monotherapy in the treatment of small cell lung cancer;
secondary purpose
To evaluate the safety and tolerability of AL8326 single agent in patients with small cell lung cancer who did not progress after first-line platinum-containing chemotherapy; to evaluate the safety of AL8326 single-agent in patients with small cell lung cancer who relapsed or progressed after first-line platinum-containing chemotherapy and tolerability; to evaluate the safety and tolerability of AL8326 monotherapy in patients with small cell lung cancer who have relapsed or progressed after at least second-line therapy;
Exploratory Purpose (Optional)
To explore the effect of AL8326 on immune cells in SCLC patients.