Sacituzumab Govitecan for Small Cell Lung Cancer
(EVOKE-SCLC-04 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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).

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.

+2 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Treatment Group B: Topotecan or Amrubicin (Japan only)Experimental Treatment2 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: SGExperimental Treatment1 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.