A Phase Ib / IIA Study of AL8326 in Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

Based on indicators such as 24 week progression free survival (24 weeks PFS) in small cell lung cancer (SCLC) patients without disease progression after first-line platinum containing chemotherapy, objective response rate (ORR) in SCLC patients with recurrence or progression after first-line platinum containing chemotherapy, and orr in SCLC patients with recurrence or progression after second-line and above treatment,Evaluation of the effectiveness of al8326 monotherapy in small cell lung cancer.

Clinical Trial Description

This trial is a multicenter, single arm, open label, nonrandomized, phase Ib / IIA trial that will evaluate the preliminary efficacy and safety of AL8326 in patients with small cell lung cancer (SCLC).Three treatment groups were used in this trial, and the study population, sample size, and basic design of each group were as follows: Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status) after first-line platinum containing chemotherapy were included, with a total sample size expected to be 79 patients. Group B: Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens, with a total sample size expected to be 79 patients. Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment (including first-line platinum containing therapy, second-line single agent or other) with a total sample size expected to be 79 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04890795
Study type	Interventional
Source	Advenchen Laboratories, LLC
Contact	yingyin Li
Phone	+8657188683590
Email	annel@advenchen.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	October 19, 2020
Completion date	September 2021

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