Sacituzumab Govitecan for Lung Cancer

(EVOKE-01 Trial)

Not currently recruiting at 279 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: 3

Duration: Up to 24.4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for advanced non-small cell lung cancer (NSCLC) by comparing sacituzumab govitecan-hziy (SG) with the existing drug, docetaxel. The goal is to determine if SG is more effective for patients whose cancer has spread and who have already undergone treatments like chemotherapy and immunotherapy. Suitable candidates have NSCLC that has progressed after specific treatments and show evidence of disease spread. Participants will receive either SG or docetaxel to assess which treatment better manages their condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks before enrolling, and you must have recovered from any side effects of previous treatments. It does not specify stopping other medications, but you should discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sacituzumab govitecan-hziy (SG) was tested in previous studies with patients. In one study, 75.4% of patients experienced serious but manageable side effects, yet only 7.1% discontinued the drug due to these effects. This indicates that while significant side effects may occur, most patients can continue treatment.

Regarding effectiveness, another study found that 83.7% of patients experienced either disease stabilization or tumor shrinkage. Sacituzumab govitecan-hziy has shown promising results in treating other types of cancer, suggesting potential safety and effectiveness for lung cancer as well. Patients should consult a healthcare provider to understand what these results might mean for their situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Sacituzumab Govitecan-hziy (SG) is unique because it combines an antibody with chemotherapy, specifically targeting cancer cells in lung cancer. While standard treatments like docetaxel target rapidly dividing cells in general, SG is designed to deliver its therapeutic payload directly to tumor cells, potentially increasing effectiveness and reducing side effects. Researchers are excited about SG because this targeted approach could improve outcomes for patients by honing in on the cancer cells more precisely than traditional chemotherapies.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that sacituzumab govitecan-hziy (SG), one of the treatments in this trial, may effectively treat lung cancer. In studies, about 42% of patients experienced tumor shrinkage, meaning nearly half saw their tumors get smaller. The benefits lasted an average of 4.7 months before the cancer began to grow again. Additionally, 43% of patients survived at least one year after treatment. These results suggest that SG could be a promising option for advanced non-small cell lung cancer (NSCLC). Participants in this trial will receive either SG or Docetaxel, another treatment option under study. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541836/

Sacituzumab govitecan: another emerging treatment option for ... Among 43 patients, the overall response rate (ORR) assessed by investigators was 41.9% [95% confidence interval (CI): 27.0–57.9%], including 18 ...

2. jto.org jto.org/article/S1556-0864(24)02549-8/fulltext

Phase 2 Open-Label Study of Sacituzumab Govitecan as ... The results from this phase 2 study indicate that patients with ES-SCLC benefit from SG treatment, with an ORR of 41.9% and a median DOR of 4.73 months per ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39755168/

Phase 2 Open-Label Study of Sacituzumab Govitecan as ... Conclusions: SG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00242

Real-World Clinical Outcomes With Sacituzumab ... The 1-year survival rate was also 43% (95% CI, 33 to 52), with a median PFS of 4.8 months (95% CI, 3.6 to 5.9). Our findings are consistent with ...

5. gilead.com gilead.com/news/news-details/2024/us-fda-grants-breakthrough-therapy-designation-to-trodelvy-sacituzumab-govitecan-hziy-for-second-line-treatment-of-extensive-stage-small-cell-lung-cancer

U.S. FDA Grants Breakthrough Therapy Designation to ... As recently presented at the IASLC 2024 World Conference on Lung Cancer, Trodelvy demonstrated promising antitumor activity in both platinum- ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424025498

Phase 2 Open-Label Study of Sacituzumab Govitecan as ... Unfortunately, the prognosis is dismal, with 2-year survival rates of 14% and 22%, respectively, and relapses occurring within 6 months in nearly all patients.

7. onclive.com onclive.com/view/sacituzumab-govitecan-generates-responses-with-manageable-safety-profile-in-es-sclc

Sacituzumab Govitecan Generates Responses With ... The disease control rate (DCR) was 83.7% (95% CI, 69.3%-93.2%), and the clinical benefit rate (CBR) was 48.8% (95% CI, 33.3%-64.5%). The median ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8575

A meta-analysis of safety and efficacy of datopotamab ... Pooled proportions (PP) for grade 3 adverse events were 34.0% (Dato-DXd) and 75.4% (SG) while drug discontinuation rates were 7.1% (Dato-DXd) ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01631552

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults ... The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day ...