NCT04890795

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

A Single Arm, Open, Non Randomized, Phase Ib / IIA Study to Evaluate the Safety and Preliminary Efficacy of AL8326 in the Treatment of Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AL8326 tablets	10mg/tablet;Oral administration, once daily.

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2021-05-18
• Last updated: 2021-05-18

Locations

9 sites across 1 country: China