A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
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
Ris-Rez
Biological/VaccineRis-Rez will be administered
Topotecan
DrugTopotecan will be administered
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Ris-RezExperimental 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
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed complete (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/Blinded Independent Central Review (BICR) assessment
Time frame
Up to approximately 139 weeks2
Duration of Response (DoR)
DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator/BICR assessment to the date of first documented PD per RECIST 1.1 by investigator/BICR assessment or death due to any cause, whichever comes first
Time frame
Up to approximately 139 weeks3
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator/BICR assessment or death from any cause, whichever occurs first
Time frame
Up to approximately 139 weeks4
Disease control rate (DCR) 12
DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator/BICR assessment
Time frame
Up to approximately 11 weeksSponsors and contacts
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Source ClinicalTrials.gov