SG + Immunotherapy for Lung Cancer

Overseen By Bindu Potugari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bindu R Potugari

Must be taking: Platinum, Etoposide, Atezolizumab, Durvalumab

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Renal impairment, Heart failure, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 45

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.

The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.

Participants in the trial will:

* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.

* CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.

* provide tissue (optional) and blood for additional testing (learn about the cancer).

Are You a Good Fit for This Trial?

Adults with extensive stage small cell lung cancer who've had 4-6 cycles of chemo/immunotherapy without disease progression. They must be able to consent, have an ECOG status of 0-2, no uncontrolled HIV/HBV/HCV, stable brain metastasis, and adequate organ function. Those with active infections or unstable brain metastasis can't join.

Inclusion Criteria

My cancer did not worsen after 4-6 rounds of chemotherapy/immunotherapy.

I've completed 4 cycles of platinum and etoposide, and 2-3 cycles of atezolizumab or Durvalumab.

I do not have active uncontrolled HIV, HBV, or HCV infections.

Exclusion Criteria

I require dialysis for kidney failure or have severe liver disease.

My cancer has spread to the lining of my brain and spinal cord.

I do not have active inflammatory bowel disease or recent severe GI issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive sacituzumab govitecan and atezolizumab/durvalumab every 21 days for up to 2 years or until disease progression or unacceptable toxicity.

Up to 2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with radiographic imaging continuing during long-term follow-up.

12 weeks

Every 12 weeks

Long-term follow-up

Survival status is assessed every 12 weeks until the participant dies, withdraws consent, or the study is terminated.

Until study completion or participant's death

Every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Durvalumab
• Sacituzumab govitecan

Trial Overview

The trial tests if sacituzumab govitecan (SG) combined with atezolizumab/durvalumab controls tumor growth in lung cancer patients. Treatment is every 21 days for up to two years, monitored by CT scans and MRI.

How Is the Trial Designed?

Group I: SG and atezolizumab/durvalumab Experimental Treatment 3 Interventions

Sacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) AND Atezolizumab 1200mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks) OR Sacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) AND Durvalumab 1500mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)

Who Is Running the Clinical Trial?

Bindu R Potugari

Lead Sponsor

Gilead Sciences

Industry 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