Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer
Status:
Active, not recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252
plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase
Ib portion will be done using time-to-event continual reassessment method (TITE-CRM)
methodology to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of
APG-1252 with a fixed dose of paclitaxel. The phase II portion will utilize a Simon two-stage
design to determine the efficacy of the combination therapy with response rate as the primary
endpoint.