Trial intelligence / Profile preview

Risvutatug rezetecan vs Topotecan in Relapsed Small Cell Lung Cancer

NCT07099898Phase 3

Key facts

Status: Recruiting
Start: Aug 2025
Primary completion: Nov 2027
Countries: 25
Sponsor: GSK
Modality: Antibody-Drug Conjugates (ADCs)

Drugs: risvutatug rezetecan
Conditions: small cell lung cancer (SCLC)

Overview

Phase 3, randomised, open-label trial of risvutatug rezetecan in small cell lung cancer (SCLC) (2 arms), sponsored by GSK. Primary endpoint: Overall Survival at 113 weeks. Started Aug 2025; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Risvutatug rezetecan (Ris-Rez)
Experimental arm receiving Risvutatug rezetecan
Topotecan
Active comparator arm receiving Topotecan

Who it enrols

Adults with extensive-stage small cell lung cancer who have progressed after prior platinum-based therapy and a PD-(L)1 inhibitor, with ECOG 0-1. Excludes patients with symptomatic brain metastases, prior TOPO1-inhibitor ADCs, active infections, or interstitial lung disease.

Endpoints

Primary

Overall Survival113 weeks

Secondary

Brain Progression-Free Survival139 weeks
Change from baseline in cough18 weeks
Change from baseline in dyspnea18 weeks
Change from baseline in chest pain18 weeks
Time to clinical deterioration in physical functioning139 weeks
Objective Response Rate139 weeks
Duration of Response139 weeks
Progression-Free Survival139 weeks

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