Informations générales (source: ClinicalTrials.gov)
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) (EVOKE-SCLC-04)
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
avril 2025
octobre 2029
12 août 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
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.
Key
- 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.