Sacituzumab Govitecan for Small Cell Lung Cancer
(EVOKE-SCLC-04 Trial)
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.12345Why 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.12567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Sacituzumab Govitecan or Standard of Care (Topotecan or Amrubicin) in 21-day cycles until disease progression, death, or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
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
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 ...
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 ...
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 ...
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-sclcSacituzumab 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 ...
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.
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).
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