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Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)
EU CTIS ID: 2025-521627-78-00
What this study is testing
To compare the antitumor activity of GSK5764227 versus topotecan in participants with relapsed small cell lung cancer (SCLC).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- "Has histologically or cytologically confirmed Extensive stage-small cell lung cancer (ES-SCLC). "
- Has received prior therapy with only one prior platinum-based systemic therapy, given for at least 2 cycles in combination with a Programmed death receptor 1 or programmed death ligand 1 [PD-(L)1] inhibitor. An exception to this requirement which allows inclusion of those previously treated with tarlatamab in the first‑ or second‑line ES‑SCLC setting.
- Has at least 1 non-brain target lesion (TL) per RECIST 1.1, as determined by the investigator.
- "Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before the first dose. "
- Has adequate organ function. Screening specimens must be collected at least 3-5 days prior to pre-dose specimens, and pre-dose specimens must be collected within 24 hours prior to first dose.
You likely can't join if
- "Prior use of or current use of treatments targeting B7 homolog 3 protein (B7-H3). "
- Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
- Pathological diagnosis of complex SCLC (such as mixed SCLC and NSCLC) or transformed SCLC (NSCLC to SCLC).
- Any evidence of current ILD or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.
- "Any of the following cardiac examination abnormalities • Has QTc >480 msec. • Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval >250 msec). • Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval. • LVEF fraction <50%. "
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to grade 1 with exceptions defined in the protocol.
See the full eligibility criteria
- "Has histologically or cytologically confirmed Extensive stage-small cell lung cancer (ES-SCLC). "
- Has received prior therapy with only one prior platinum-based systemic therapy, given for at least 2 cycles in combination with a Programmed death receptor 1 or programmed death ligand 1 [PD-(L)1] inhibitor. An exception to this requirement which allows inclusion of those previously treated with tarlatamab in the first‑ or second‑line ES‑SCLC setting.
- Has at least 1 non-brain target lesion (TL) per RECIST 1.1, as determined by the investigator.
- "Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before the first dose. "
- Has adequate organ function. Screening specimens must be collected at least 3-5 days prior to pre-dose specimens, and pre-dose specimens must be collected within 24 hours prior to first dose.
- "Prior use of or current use of treatments targeting B7 homolog 3 protein (B7-H3). "
- Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
- Pathological diagnosis of complex SCLC (such as mixed SCLC and NSCLC) or transformed SCLC (NSCLC to SCLC).
- Any evidence of current ILD or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.
- "Any of the following cardiac examination abnormalities • Has QTc >480 msec. • Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval >250 msec). • Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval. • LVEF fraction <50%. "
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to grade 1 with exceptions defined in the protocol.
- History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins, DNA topoisomerase I inhibitor or regimens of Topotecan.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- Canada
- Mexico
- United Kingdom
- Brazil
- Israel
- United States
- Turkey
- Australia
- Japan
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; Canada; Mexico; United Kingdom; Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.