Sacituzumab Govitecan for Small Cell Lung Cancer

(EVOKE-SCLC-04 Trial)

Recruiting at 4 trial locations

Overseen By Gilead Clinical Study Information Cente

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must not be taking: Irinotecan, Topotecan, others

Disqualifiers: Untreated CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: Up to 4.5 years

695 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for people with a specific lung cancer (ES-SCLC) who've already had one round of platinum-based chemo. They should be fairly active and healthy otherwise (ECOG score 0 or 1), have measurable cancer on scans, and show that their cancer has gotten worse after treatment.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer is confirmed as small cell lung cancer.

My cancer can be measured on scans according to specific criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sacituzumab Govitecan or Standard of Care (Topotecan or Amrubicin) in 21-day cycles until disease progression, death, or unacceptable toxicity

Up to 4.5 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sacituzumab Govitecan

Trial Overview The study compares Sacituzumab Govitecan (SG), a new drug, against the standard treatments for this stage of lung cancer. The main goals are to see if SG improves response rates and survival times better than existing options.

Participant Groups

Group I: Treatment Group B: Topotecan or Amrubicin (Japan only) Experimental Treatment 2 Interventions

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.

Group II: Treatment Group A: SG Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine