A Global, Multicer, 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)
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)
Akiyama Masanao
Gilead Sciences K.K.
1-9-2, Marunouchi, Chiyoda-ku
+81-3-6705-1603
ClinicalTrialGSJ@gilead.com
Clinical Operations
Gilead Sciences K.K.
1-9-2, Marunouchi, Chiyoda-ku
+81-3-6837-0773
JPClinicalOperations@gilead.com
Recruiting
June. 01, 2025
695
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
- Histologically or cytologically 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.
- Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
- If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
- If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.
- 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.
- 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 a dose of 10 mg/day or less 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.
18age old over
No limit
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Treatment Group A: Sacituzumab Govitecan (SG) will be administered by intravenous (IV) infusion. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
- Drug: SG
- Other Names: Trodelvy , GS-0132, IMMU 132
SG 10 mg/kg will be administered as an IV infusion on Days 1 and 8 of a 21-day cycle.
Treatment Group B: Topotecan or Amrubicin (Japan only) will be administered by intravenous (IV) infusion. Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
- Drug: Topotecan
Topotecan 1.5 mg/m^2 daily will be administered as an IV infusion on Days 1 to 5 of a 21-day cycle.
- Drug: Lurbinectedin 3.2 mg/m^2 administered as an intravenous infusion on Day 1 of a 21-day cycle. (in countries/regions where lurbinectedin is approved and available).
- Drug: Amrubicin (Japan only)
Amrubicin 40 mg/m^2 daily will be administered as an IV infusion on Days 1 to 3 of a 21-day cycle.
Overall Survival (OS) [Time Frame: Up to 4.5 years]
- OS is defined as length of time from randomization until the date of death from any cause.
Progression-free Survival (PFS) [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.
Objective Response Rate (ORR) [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.
Duration of Response (DOR) [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 to First Deterioration in Shortness of Breath Domain [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 to First Deterioration in Physical Functioning Domain [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.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [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.
Percentage of Participants Experiencing Clinical Laboratory abnormalities [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.
Gilead Sciences K.K.
Kyushu University Hospital Institutional Review Board for Clinical Trials
