Sacituzumab Govitecan for Lung Cancer

(EVOKE-01 Trial)

Recruiting at 235 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must not be taking: Topoisomerase inhibitors, Trop-2 therapy

Disqualifiers: Active second malignancy, 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: Unknown

603 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for adults with advanced or metastatic NSCLC who have already tried a platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. They must have proper liver function, no active second cancers, no brain metastases, and not be pregnant or breastfeeding. Participants need to have recovered from previous treatments' side effects and can't join if they've had certain other cancer therapies.

Inclusion Criteria

I agree to use birth control as specified by the study.

My lung cancer is confirmed to be at stage 4.

My kidneys work well enough to clear at least 30 mL/min of creatinine.

Exclusion Criteria

I haven't had cancer treatment or still have side effects from the last one.

I still have significant side effects from a previous treatment.

I have been treated with specific cancer drugs like Topoisomerase 1 inhibitors, Trop-2 therapy, or Docetaxel.

Treatment Details

Interventions

• Docetaxel
• Sacituzumab Govitecan-hziy (SG)

Trial Overview The study compares Sacituzumab Govitecan (SG) with Docetaxel in treating NSCLC. Patients will be randomly assigned to receive either SG or Docetaxel to determine which is more effective at controlling the disease.

Participant Groups

Group I: Sacituzumab Govitecan-hziy (SG) Experimental Treatment 1 Intervention

Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Group II: Docetaxel Active Control 1 Intervention

Participants will receive docetaxel 75 mg/m\^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

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