RecruitingPhase 2Phase 3NCT05623267

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

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


Sponsor

Sun Yat-sen University

Enrollment

346 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called sugemalimab (an immunotherapy) helps prevent small cell lung cancer from coming back after patients complete chemotherapy combined with radiation. It is designed for people with limited-stage small cell lung cancer — meaning the cancer has not spread widely beyond the chest. **You may be eligible if...** - You are 18 or older with small cell lung cancer confirmed by biopsy - Your cancer is limited-stage (confined to a region that can be treated with radiation) - You have completed 4 cycles of chemotherapy (with etoposide and carboplatin or cisplatin) given together with or sequentially with radiation - Your cancer did not grow during that treatment - You are generally active and able to care for yourself (good performance status) **You may NOT be eligible if...** - Your cancer has spread widely (extensive-stage) - You have a mixed type of lung cancer or pleural/pericardial fluid from the cancer - You have had prior immunotherapy or any prior treatment for this cancer - You have an active uncontrolled infection, heart failure, or serious organ disease - You have a history of severe lung inflammation (interstitial lung disease) - You have had another cancer in the past 5 years (with minor exceptions) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSugemalimab

Recombinant anti-PD-L1 fully human monoclonal antibody

DRUGPlacebo

Placebo of Sugemalimab


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05623267


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