About this trial
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).
The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of SCLC.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
Disqualifiers
Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) < 30 days (independent of the immunotherapy maintenance).
Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.
Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.
Trial design
Parallel
Treatments tested in this trial
Sacituzumab Govitecan (SG)
DrugAdministered intravenously
Topotecan
DrugAdministered intravenously
Amrubicin (Japan only)
DrugAdministered intravenously
Lurbinectedin (regions/countries where approved and available)
DrugAdministered intravenously
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival (OS)
OS is defined as length of time from randomization until the date of death from any cause.
Secondary outcomes
Progression-free Survival (PFS)
PFS is defined as the time from date of randomization until disease progression as assessed by investigator according to RECIST v1.1 or death from any cause, whichever comes first.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have achieved a CR or PR as assessed by investigator according to RECIST v1.1.
Duration of Response (DOR)
DOR is defined as is measured from the time of first response (CR or PR) as assessed by investigator according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first
Time to First Deterioration in Shortness of Breath Domain
Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.
Sponsors and contacts
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