Clinical trial • Phase III • Oncology
sacituzumab govitecan for Extensive-stage small cell lung cancer
Phase III trial of sacituzumab govitecan for Extensive-stage small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive-stage small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC | Small molecule
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 27-05-2025
Trial design
Randomised, open-label, intervention: trodelvy (sacituzumab govitecan) 200 mg powder for concentrate for solution for infusion; intravenous route; dosing unit mg/kg (max daily 12 mg/kg); 21-day treatment period indicated in product metadata. comparator: hycamtin (topotecan) 4 mg powder for concentrate for solution for infusion; intravenous route; dosing unit mg/m2 (max daily 2.3 mg/m2); 21-day treatment period indicated in product metadata.-controlled Phase III trial in Belgium, France, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Intervention: Trodelvy (sacituzumab govitecan) 200 mg powder for concentrate for solution for infusion; intravenous route; dosing unit mg/kg (max daily 12 mg/kg); 21-day treatment period indicated in product metadata. Comparator: HYCAMTIN (topotecan) 4 mg powder for concentrate for solution for infusion; intravenous route; dosing unit mg/m2 (max daily 2.3 mg/m2); 21-day treatment period indicated in product metadata.
- Target Sample Size
- 435
Eligibility
Recruits 435 adults.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed diagnosis of SCLC.\n- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.\n- 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 (Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy)"}
Exclusion criteria
- {"criterion_text":"- 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).\n- Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by blinded independent central review (BICR) according to RECIST v1.1"}
- {"endpoint_text":"- OS is defined as length of time from randomization until the date of death from any cause","definition_or_measurement_approach":"OS is defined as length of time from randomization until the date of death from any cause"}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"PFS is defined as the time from date of randomization until disease progression as assessed by blinded independent central review (BICR) according to RECIST v1.1 or death from any cause, whichever comes first"}
- {"endpoint_text":"- 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","definition_or_measurement_approach":"DOR 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"}
- {"endpoint_text":"- Time to first deterioration in shortness of breath","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to first deterioration in physical functioning","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities as captured in safety assessments"}
Recruitment
- Planned Sample Size
- 435
- Recruitment Window Months
- 52
- Consent Approach
- Informed consent is obtained using subject information sheets and ICF documents. ICF/SIS materials and related consent documents are available in multiple country-specific languages (examples in the submission: EN, FR, NL, DE, HU, PL, IT, ES, RO, NO, EL). Optional/ancillary consent forms are provided for items such as pregnant partner information, treatment beyond progression, optional genomic research, tumor biopsy and Greenphire/eCOA use (these specific ICFs are listed among submitted documents).
Methods
- Doctor-to-Patient letter: recruitment material (document titles include 'Dr-to-Patient Letter' / 'Doctor to Patient Letter') distributed via healthcare professionals to potential participants; language/country-specific versions available.
- Doctor-to-Doctor letter: HCP-to-HCP communication to inform referring clinicians about the trial and identify potential participants; country-specific versions present.
- Patient flyer / Patient Study Guide: printed or electronic flyers for patients (titles present in multiple languages) to raise awareness among patients.
- Site Conversation Guide: materials to support site staff conversations with potential participants.
- Patient ID cards / Wallet cards / Patient comfort kits referenced among subject information materials to support recruitment and retention.
Geography
- Total Number Of Participants
- 435
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 244
- Number Of Participants
- 16
France
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 283
- Number Of Participants
- 34
Germany
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 312
- Number Of Participants
- 27
Greece
- Earliest CTIS Part Ii Submission Date
- 14-02-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 438
- Number Of Participants
- 19
Hungary
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 288
- Number Of Participants
- 8
Italy
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 269
- Number Of Participants
- 30
Romania
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 256
- Number Of Participants
- 25
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 308
- Number Of Participants
- 15
Spain
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 308
- Number Of Participants
- 56
Norway
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 268
- Number Of Participants
- 9
Poland
- Earliest CTIS Part Ii Submission Date
- 24-04-2025
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 266
- Number Of Participants
- 15
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA RDS Hellas Single Member S.A.
- Responsibilities
- On Site Monitoring Investigator Recruitment Project Management Regulatory Expertise
- Name
- IQVIA Limited
- Responsibilities
- On Site Monitoring Investigator Recruitment Project Management Regulatory Expertise
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging Services
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central Laboratory. Providing lab kits and sample storage. Shipping samples to third parties for analysis.
- Name
- Greenphire LLC
- Responsibilities
- Patient Travel and Reimbursement
Third parties
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"On Site Monitoring Investigator Recruitment Project Management Regulatory Expertise","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"On Site Monitoring Investigator Recruitment Project Management Regulatory Expertise","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Provide eCOA Questionnaires and provisioned devices","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory. Providing lab kits and sample storage. Shipping samples to third parties for analysis.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Survival Follow up","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Trodelvy 200 mg powder for concentrate for solution for infusion
- Active Substance
- sacituzumab govitecan
- Modality
- ADC
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation (EU marketing authorisation number EU/1/21/1592/001)
- Frequency
- 21-day treatment period indicated in product metadata
- Maximum Dose
- 12 mg/kg (max daily amount as listed)
- Investigational Product Name
- HYCAMTIN 4 mg powder for concentrate for solution for infusion
- Active Substance
- topotecan
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation (marketingAuthNumber EU/1/96/027/003)
- Frequency
- 21-day treatment period indicated in product metadata
- Maximum Dose
- 2.3 mg/m2 (max daily amount as listed)
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