Actively Recruiting
Phase 3 Randomized Study of GSK5764227, a B7-H3 Antibody Drug Conjugate, Compared With Topotecan in Relapsed Small Cell Lung Cancer
Led by GlaxoSmithKline · Updated on 2026-05-27
420
Participants Needed
120
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Risvutatug rezetecan Ris-Rez, a new medicine targeting specific proteins B7-H3 on cancer cells to reduce the growth and spread of relapsed small cell lung cancer SCLC. This Phase 3 study compares Ris-Rez to the standard treatment, topotecan, to see how well Ris-Rez shrinks or eliminates tumors and whether it helps participants live longer. The study also monitors safety and side effects of both treatments to understand their tolerability. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Ris-Rez is a biological treatment given to target the cancer cells, while topotecan is a drug used as the active comparator. The study involves multiple assessments over time, including treatment response and disease progression, lasting up to approximately 139 weeks for some measures. During the study, participants will undergo regular evaluations including imaging scans to assess tumor response, laboratory tests to monitor organ function and side effects, ECGs to check heart function, and assessments of physical activity levels using ECOG performance status. Researchers will also measure overall survival, progression-free survival, adverse events, and participant experiences with the treatments. The total participation duration lasts up to about 113 weeks for overall survival and up to 139 weeks for other secondary outcomes.
CONDITIONS
Brief Title
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- Received at least 1 prior platinum-based systemic therapy with a PD-(L)1 inhibitor for at least 2 cycles, with documented disease progression and a chemotherapy-free interval of more than 30 days
- May have had prior tarlatamab treatment in first- or second-line ES-SCLC
- Has at least 1 target lesion measurable by RECIST 1.1 criteria
- Capable of providing signed informed consent and complying with study requirements
- Adequate organ function and an ECOG performance status of 0 or 1
You will not qualify if you...
- Diagnosis of complex or transformed small cell lung cancer
- Limited stage small cell lung cancer at initial diagnosis
- Prior treatment with an antibody-drug conjugate containing a Topoisomerase-1 inhibitor or therapies targeting B7-H3
- Known sensitivity or allergy to study drug components that contraindicate participation
- Severe, uncontrolled, or active cardiovascular disease
- Significant bleeding symptoms or bleeding tendency within 1 month before first dose
- Active infections requiring systemic treatment or known HIV infection
- Symptomatic brain metastases or untreated brain progression, leptomeningeal or brainstem metastases, or spinal cord metastases
- Current or prior interstitial lung disease or pneumonitis requiring high-dose steroids
- Significant pulmonary disease or respiratory impairment such as uncontrolled asthma or COPD
- Active Hepatitis B or Hepatitis C infection
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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