A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
ConditionNeoplasms, Lung
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Risvutatug rezetecan (Ris-Rez)
Biological/VaccineRis-Rez will be administered
Topotecan
DrugTopotecan will be administered
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Risvutatug rezetecan (Ris-Rez)Experimental treatment 1 intervention
Group B: TopotecanActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death by any cause
Time frame
Up to approximately 113 weeksSecondary outcomes
1
Brain PFS
Brain PFS is defined as the time from the date of randomization to the date of first documented PD per modified Response assessment in neuro-oncology (RANO-BM) by BICR assessment or death from any cause, whichever occurs first in participants with history of brain metastasis or presence of brain metastasis at baseline
Time frame
Up to approximately 139 weeks2
Change from baseline in cough
Validated questionnaires will be used for the assessment
Time frame
Up to approximately 18 weeks3
Change from baseline in dyspnea
Validated questionnaires will be used for the assessment
Time frame
Up to approximately 18 weeks4
Change from baseline in chest pain
Validated questionnaires will be used for the assessment
Time frame
Up to approximately 18 weeksSponsors and contacts
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Source ClinicalTrials.gov