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

Sponsor: Bindu R Potugari

Sponsor score: 0

ClinicalTrials ID:NCT07339059

Provider View

This clinical trial is testing a combination of drugs, sacituzumab govitecan and atezolizumab/durvalumab, to see if they can effectively control tumor growth in adults with extensive-stage small cell lung cancer. These drugs are already approved for use in other cancers, and this study aims to find out if they work well together for this type of lung cancer.

Patient Parameters

Program Overview

The purpose of this study is to determine if combining sacituzumab govitecan with atezolizumab or durvalumab can help control the growth of tumors in patients with extensive-stage small cell lung cancer (SCLC). These drugs are already approved for other cancers, and this study will evaluate their effectiveness together. Participants will receive the treatment every 21 days for up to two years or until it no longer works. The effectiveness will be measured by changes in tumor size and the appearance of new tumors. Participants will also have regular CT and MRI scans and may provide tissue and blood samples for further testing.

Description

Small Cell Lung Cancer (SCLC) is a fast-growing type of lung cancer that often spreads quickly. Most patients are diagnosed at an advanced stage, and the survival rate is low. Current treatments, like chemotherapy combined with immunotherapy, have limited success. This study is exploring a new combination of drugs to improve outcomes for patients with advanced SCLC.

Sacituzumab govitecan (SG) is a drug that targets a protein called TROP-2, which is found in many cancers, including SCLC. It works by delivering a toxic substance directly to cancer cells. Previous studies have shown that SG can reduce tumor size in some patients with SCLC. This study will combine SG with atezolizumab or durvalumab, which are immunotherapy drugs that help the immune system attack cancer cells.

The study will enroll patients who have already completed at least 4-6 cycles of chemotherapy and immunotherapy and have stable disease or partial response. Participants will receive SG and atezolizumab or durvalumab every three weeks for up to two years. The study will monitor the safety and effectiveness of the treatment, with regular scans and follow-up visits to track progress and side effects. The goal is to see if this combination can improve survival and control the cancer better than current treatments.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to give informed consent.
  • Male or female aged 18 years or older.
  • Diagnosed with extensive-stage small cell lung cancer (SCLC) or locally advanced disease that cannot be treated with radiation.
  • Completed at least four cycles of platinum-based chemotherapy and 2-3 cycles of atezolizumab or durvalumab.
  • No signs of cancer progression on recent scans.
  • ECOG performance status of 0-2, meaning fully active or with some limitations but able to care for oneself.
  • No active, uncontrolled infections like HIV, HBV, or HCV. Well-controlled infections are allowed.
  • Stable and asymptomatic brain metastases.
  • Adequate organ function, including bone marrow, kidney, and liver.

Exclusion Criteria

  • Severe kidney problems requiring dialysis or severe liver disease.
  • Leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
  • Recent heart failure or coronary disease within the last 3 months.
  • Unable to receive immunotherapy with chemotherapy for initial treatment or had to stop immunotherapy due to side effects.
  • Active inflammatory bowel disease or recent gastrointestinal perforation.
  • Previous treatment with certain immunotherapy drugs within the last 12 months.

Locations

FACILITYZIPCITYSTATE
Henry Ford Cancer- Detroit48202DetroitMichigan

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