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)
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
avril 2025
octobre 2029
26 juin 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 04/09/2025 13:15:04 | Contacter | ||
Critères
Tous
- 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.
- 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.
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:
- 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. Received lurbinectedin
after progression on or after platinum-based chemotherapy.
- 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 ≤ 10 mg/day 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.