Spots Global Cancer Trial Database for Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

Official Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy

Study ID: NCT05623267

Conditions

Limited Stage Small Cell Lung Cancer

Interventions

Sugemalimab

Placebo

Study Description

Brief Summary: The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.

Detailed Description: This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.