Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Phase 3

Recruiting

• Conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC)
• Interventions: Drug: Sacituzumab Govitecan (SG); Drug: Topotecan; Drug: Amrubicin (Japan only)

• Registration Number: NCT06801834
• Lead Sponsor: Gilead Sciences

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Study Start: 2025-04-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 695

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group A: SG	Sacituzumab Govitecan (SG)	Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment Group B: Topotecan or Amrubicin (Japan only)	Topotecan	Participants assigned to treatment group B will receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle. Japan participants assigned to treatment group B will have the option to receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle, or Amrubicin 40 mg/m\^2 daily on Days 1 to 3 of a 21-day cycle. Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment Group B: Topotecan or Amrubicin (Japan only)	Amrubicin (Japan only)	Participants assigned to treatment group B will receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle. Japan participants assigned to treatment group B will have the option to receive Topotecan 1.5 mg/m\^2 daily on Days 1 to 5 of a 21-day cycle, or Amrubicin 40 mg/m\^2 daily on Days 1 to 3 of a 21-day cycle. Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 4.5 years	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
Overall Survival (OS)	Up to 4.5 years	OS is defined as length of time from randomization until the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Clinical Laboratory abnormalities	First dose date up to 4.5 years	Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.
Progression-free Survival (PFS)	Up to 4.5 years	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.
Duration of Response (DOR)	Up to 4.5 years	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
Time to First Deterioration in Shortness of Breath Domain	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	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)	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.

Trial Locations

Locations (5)

Cancer Care Wollongong; 🇦🇺 New South Wales, Australia

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States

Hope and Healing Cancer Services; 🇺🇸 Hinsdale, Illinois, United States

Taylor Cancer Research Foundation; 🇺🇸 Toledo, Ohio, United States

Spoknwrd Clinical Trials Inc.; 🇺🇸 Easton, Pennsylvania, United States