RecruitingPhase 2NCT07339059

Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer


Sponsor

Bindu R Potugari

Enrollment

35 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether continuing treatment with sacituzumab govitecan (an antibody-drug combination, SG) plus immunotherapy (atezolizumab or durvalumab) as ongoing maintenance therapy can help keep extensive-stage small-cell lung cancer under control after initial chemotherapy and immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed extensive-stage small-cell lung cancer - You completed at least 4 cycles of platinum/etoposide chemotherapy plus 2–3 cycles of immunotherapy (atezolizumab or durvalumab) with no signs of progression - Your cancer is stable or responding on the most recent scan - You are in reasonably good health (ECOG 0–2) with adequate organ function - Stable brain metastases are allowed **You may NOT be eligible if...** - Your cancer has spread to the lining of the brain (leptomeningeal disease) - You have severe kidney or end-stage liver disease - You had a recent diagnosis of heart failure or heart attack (within 3 months) - Immunotherapy was stopped due to serious immune-related side effects - You have active inflammatory bowel disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

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)

DRUGAtezolizumab

Atezolizumab 1200mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)

DRUGDurvalumab

Durvalumab 1500mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)


Locations(1)

Henry Ford Cancer- Detroit

Detroit, Michigan, United States

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NCT07339059


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