At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Risvutatug rezetecan (Ris-Rez) (biological), Topotecan (drug)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Risvutatug rezetecan (Ris-Rez) — biological: Ris-Rez will be administered · Topotecan — drug: Topotecan will be administered
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 420
- Started
- 2025-08-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms, lung
- • Phase3 - 420 participants
- • In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms, lung
Where?
- • London - GSK Investigational Site
- • Portsmouth - GSK Investigational Site
- • Truro - GSK Investigational Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Participants are eligible to be included in the study only if all of the following criteria apply:
- ✓Adults \>18 or the minimum legal adult age at the time the agreement to take part form is signed
- ✓Has confirmed by testing a sample extensive-stage small cell lung cancer (ES-SCLC).
- ✓Has at least 1 target lesion per (standard scan measurements), as determined by the investigator.
- ✓Is capable of giving signed agreement to take part, including compliance with the requirements and restrictions listed in...
Who cannot take part
- ✗Participants are excluded from the study if any of the following criteria apply:
- ✗Pathological diagnosis of complex SCLC or transformed SCLC.
- ✗Limited stage small cell lung cancer at diagnosis
- ✗Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor...
- ✗Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the...
See the full criteria
Where Is This Study? (3 UK sites)
GSK Investigational Site
London W1G 6AD, United Kingdom
GSK Investigational Site
Portsmouth PO6 3LY, United Kingdom
GSK Investigational Site
Truro TR1 3LJ, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
