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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06801834
Registration number
NCT06801834
Ethics application status
Date submitted
24/01/2025
Date registered
30/01/2025
Date last updated
24/06/2025
Titles & IDs
Public title
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
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Scientific title
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)
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Secondary ID [1]
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2024-515884-69
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Secondary ID [2]
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GS-US-600-6165
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Universal Trial Number (UTN)
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Trial acronym
EVOKE-SCLC-04
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan (SG)
Treatment: Drugs - Topotecan
Treatment: Drugs - Amrubicin (Japan only)
Experimental: Treatment Group A: SG - Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Experimental: Treatment Group B: Topotecan or Amrubicin (Japan only) - Participants assigned to treatment group B will receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle.
Japan participants assigned to treatment group B will have the option to receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle, or Amrubicin 40 mg/m\^2 daily on Days 1 to 3 of a 21-day cycle.
Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment: Drugs: Sacituzumab Govitecan (SG)
Administered intravenously
Treatment: Drugs: Topotecan
Administered intravenously
Treatment: Drugs: Amrubicin (Japan only)
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1
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Timepoint [1]
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Up to 4.5 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as length of time from randomization until the date of death from any cause.
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Timepoint [2]
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Up to 4.5 years
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from date of randomization until disease progression as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first.
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Timepoint [1]
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Up to 4.5 years
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as is measured from the time of first response (CR or PR) as assessed by BICR according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first
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Timepoint [2]
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Up to 4.5 years
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Secondary outcome [3]
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Time to First Deterioration in Shortness of Breath Domain
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 4.5 years
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Secondary outcome [4]
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Time to First Deterioration in Physical Functioning Domain
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 4.5 years
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Secondary outcome [5]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [5]
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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.
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Timepoint [5]
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First dose date up to 4.5 years
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Secondary outcome [6]
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Percentage of Participants Experiencing Clinical Laboratory abnormalities
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Assessment method [6]
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Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.
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Timepoint [6]
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First dose date up to 4.5 years
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2029
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Actual
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Sample size
Target
695
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cancer Care Wollongong - New South Wales
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Recruitment postcode(s) [1]
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2500 - New South Wales
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Indiana
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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China
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State/province [6]
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Changchun
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Country [7]
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China
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State/province [7]
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Linyi
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Country [8]
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Japan
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State/province [8]
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Fukuoka
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Country [9]
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Korea, Republic of
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State/province [9]
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Changwon-Si
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Country [10]
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Korea, Republic of
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State/province [10]
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Gwangju
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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Korea, Republic of
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State/province [12]
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Ulsan
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Country [13]
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Taiwan
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State/province [13]
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Kaohsiung City
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Country [14]
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Taiwan
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State/province [14]
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Tainan
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Country [15]
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Taiwan
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State/province [15]
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Taoyuan City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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 objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).
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Trial website
https://clinicaltrials.gov/study/NCT06801834
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gilead Clinical Study Information Cente
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Address
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Country
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Phone
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1-833-445-3230 (GILEAD-0)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06801834
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