Sacituzumab Govitecan (SG)
DrugAdministered intravenously
Other names: Trodelvy®, GS-0132, IMMU 132
NCT Number: NCT06801834
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy.
Refer to protocol for country-specific requirements for participants in China.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered intravenously
Other names: Trodelvy®, GS-0132, IMMU 132
Administered intravenously
Administered intravenously
Administered intravenously
Time frame: Up to 4.5 years
OS is defined as length of time from randomization until the date of death from any cause.
Time frame: Up to 4.5 years
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.
Time frame: Up to 4.5 years
ORR is defined as the percentage of participants who have achieved a CR or PR as assessed by investigator according to RECIST v1.1.
Time frame: Up to 4.5 years
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 frame: Up to 4.5 years
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.
Time frame: Up to 4.5 years
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.
Time frame: First dose date up to 4.5 years
TEAE is defined as any AEs occurred during the treatment-emergent period. The treatment-emergent period is defined as the time period from the first dose of study treatment to the earlier of 30 days following the last dose of study treatment or the initiation of subsequent anticancer therapy.
Time frame: First dose date up to 4.5 years
Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.
Contact information is provided by the study sponsor or research team.
Gilead Sciences
Industry
A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Acronym: EVOKE-SCLC-04
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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