AL8326 in Small Cell Lung Cancer
Research type
Research Study
Full title
Phase III Clinical Study of AL8326 Tablets in Patients with Advanced or Recurrent Small Cell Lung Cancer after at Least Prior Second-line Treatment
IRAS ID
1008426
Contact name
Paul Chen
Contact email
Sponsor organisation
Advenchen Pharmaceuticals
Research summary
This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy and safety of AL8326 tablets in patients with advanced or recurrent small cell lung cancer (SCLC) after at least prior second-line treatment.
Eligible patients will be randomized in a 2:1 ratio to receive AL8326 tablets or placebo (dummy pill). AL8326 tablets and placebo will be administered orally once daily in 28-day as one cycle until intolerable toxicity, or confirmed disease progression, or death, or
voluntary withdrawal or treatment for up to 12 months (approximately 13 cycles). Patients will have a final visit (28 days ± 7 days) after the last dose, or 12 months (approximately 13 cycles) of treatment (± 7 days), or before initiation of other antineoplastic therapy, or withdrawal, whichever came first. Patients then will enter the long-term follow-up period and will have telephone calls every 2-4 months for 1 year, then every 4-5 months for 2 years, and finally every 6-8 months for study survival follow-up.
Patients who have good response at the end of the treatment can remain on the study on blinded treatment on compassionate grounds.REC name
Wales REC 2
REC reference
23/WA/0329
Date of REC Opinion
28 Mar 2024
REC opinion
Further Information Favourable Opinion