Sacituzumab Govitecan for Lung Cancer
(EVOKE-01 Trial)

Recruiting in Palo Alto (17 mi)

+235 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

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).

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.

+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.

+12 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 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: DocetaxelActive Control1 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: