603 Participants Needed

Sacituzumab Govitecan for Lung Cancer

(EVOKE-01 Trial)

Recruiting at 235 trial locations
GC
Overseen ByGilead Clinical Study Information Center
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

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.
See 9 more

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.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sacituzumab govitecan-hziy (SG) or docetaxel in 21-day cycles until progression, death, or unacceptable toxicity

Up to 24.4 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3.5 years

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention
Group II: DocetaxelActive Control1 Intervention

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

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

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