Sacituzumab Govitecan for Small Cell Lung Cancer

(EVOKE-SCLC-04 Trial)

Recruiting at 164 trial locations

Overseen By Gilead Clinical Study Information Cente

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must not be taking: Irinotecan, Topotecan, others

Disqualifiers: Untreated 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: 21

Duration: Up to 4.5 years

695 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sacituzumab govitecan, an antibody-drug conjugate, for individuals with small cell lung cancer that has spread extensively and worsened after chemotherapy. Researchers aim to determine if this new treatment is more effective than standard treatments at shrinking tumors and extending life. Participants will receive either the new treatment or a standard treatment such as topotecan or, in Japan, amrubicin. This trial suits those diagnosed with small cell lung cancer who have undergone chemotherapy with platinum and experienced cancer progression since. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that sacituzumab govitecan (SG) is generally well-tolerated. In earlier studies, patients with advanced small cell lung cancer (ES-SCLC) who received SG experienced mostly mild side effects, manageable with regular medical care.

The safety profile of SG aligned with observations from other studies, revealing few surprises. While some patients did experience side effects, these were usually not severe. This suggests that SG has a safety record that supports further testing for treating ES-SCLC. ^{1 2 3 4 5}

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

Researchers are excited about Sacituzumab Govitecan for small cell lung cancer because it represents a novel approach by combining an antibody with a chemotherapy drug. Unlike traditional chemotherapy options like cisplatin and etoposide, this treatment targets the tumor directly, delivering the chemotherapy agent right to the cancer cells and potentially reducing side effects on healthy cells. This targeted delivery system is different from the broad-acting nature of standard treatments and promises to enhance effectiveness while minimizing harm to the rest of the body.

What evidence suggests that sacituzumab govitecan might be an effective treatment for small cell lung cancer?

Research has shown that sacituzumab govitecan (SG), which participants in Treatment Group A may receive, could be a promising treatment for extensive stage small cell lung cancer (ES-SCLC). Studies found that SG helped shrink tumors in about 42% of patients, with benefits lasting nearly five months on average. The side effects were manageable and not too severe. Overall, these findings suggest SG could be an effective option for patients with ES-SCLC. ^{1 2 5 6 7}

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 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.

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 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

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group B: Topotecan or Amrubicin (Japan only) Experimental Treatment 2 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: SG Experimental Treatment 1 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.

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. 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 ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424009080

OA04.04 Sacituzumab Govitecan as Second-Line ... In the efficacy analysis (n=43), ORR was 41.9% and CBR was 48.8% (Table). The median DOR was 4.73 months (95% CI, 3.52-6.70), median PFS was 4.40 months (95% CI ...

4. esmoopen.com esmoopen.com/article/S2059-7029(24)00407-1/fulltext

Efficacy results by histology from the EVOKE-02 study SG, a Trop-2–directed antibody-drug conjugate, has demonstrated activity and manageable safety in heavily pretreated patients with mNSCLC.

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

Sacituzumab Govitecan Generates Responses With ... Updated data showed that the median duration of treatment was 4.4 months (range, 0.03-18.04), and patients received a median of 7 treatment ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8599

Longer follow-up for survival and safety from the EVOKE ... Long-term safety showed SG is well tolerated, consistent with minimal increase in AE rates since prior report and an improved safety profile over docetaxel.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06801834

NCT06801834 | Study of Sacituzumab Govitecan Versus ... Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04).