NCT07099898 A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
| NCT ID | NCT07099898 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Condition | Neoplasms, Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2027-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2025-08-11 with a primary completion date of 2027-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 informed consent form is signed * Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible. * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. * Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol. * Has adequate organ function and an ECOG performance status of 0 or 1 Exclusion Criteria: 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 payload or treatments targeting B7-H3. * Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. * Has severe, uncontrolled or active cardiovascular disorders. * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV). * Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. * Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids. * Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease), * Has active Hepatitis B or Hepatitis C
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07099898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms, Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07099898 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT07099898 currently recruiting?
Yes, NCT07099898 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07099898 trial being conducted?
This trial is being conducted at Mar del Plata, Argentina, Buenos Aires, Argentina, Ciudad Autonoma de Buenos Aire, Argentina, Ciudad Autonoma de Buenos Aire, Argentina and 11 additional locations.
Who is sponsoring the NCT07099898 clinical trial?
NCT07099898 is sponsored by GlaxoSmithKline. The trial plans to enroll 420 participants.