Clinical trial NCT06801834: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Key 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 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 4.5 years
measure: Overall Survival (OS)
timeFrame: Up to 4.5 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 4.5 years
measure: Duration of Response (DOR)
timeFrame: Up to 4.5 years
measure: Time to First Deterioration in Shortness of Breath Domain
timeFrame: Up to 4.5 years
measure: Time to First Deterioration in Physical Functioning Domain
timeFrame: Up to 4.5 years
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 4.5 years
measure: Percentage of Participants Experiencing Clinical Laboratory abnormalities
timeFrame: First dose date up to 4.5 years
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: Toledo
country: United States
facility: Taylor Cancer Research Foundation
state: Ohio
city: Easton
country: United States
facility: Spoknwrd Clinical Trials Inc.
state: Pennsylvania
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
city: New South Wales
country: Australia
facility: Cancer Care Wollongong
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: