Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
Bindu R Potugari
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).
Description
Small Cell Lung Cancer (SCLC) is a high-grade neuroendocrine tumor, accounting for nearly 15% of all lung cancers. It is characterized by rapid doubling time, high vascularity, apoptotic imbalance, and early widespread hematogenous metastasis. More than two-thirds of the patients present with extensive stage and only one-third of them present with limited stage confined to the chest. Prognosis continues to be poor with a 3yr relative survival rate of 13%. Despite high response rate with platinum-based chemotherapy, the median survival is limited in patients with advanced SCLC due to early recu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial. * Male or Female aged 18 years or above. * Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation. * Participants must have received at least four cycles of platinum plus etoposide and at least 2-3 cycles of atezolizumab/ Durvalumab. * No evidence of progression on restaging CT CAP following 4-6 cycles of Chemo/IO from the…
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)
Location
- Henry Ford Cancer- DetroitDetroit, Michigan