Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Treatments: Drug: Topotecan; Drug: Sacituzumab Govitecan (SG); Drug: Amrubicin (Japan only)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06801834

GS-US-600-6165

2024-515884-69 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 695 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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695 participants in 2 patient groups

Treatment Group A: SG

Experimental group

Description:

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:

Drug: Sacituzumab Govitecan (SG)

Treatment Group B: Topotecan or Amrubicin (Japan only)

Experimental group

Description:

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:

Drug: Amrubicin (Japan only)

Drug: Topotecan