NCT07339059 · Bindu R Potugari
Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
What this study is about
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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 last dose of the chemotherapy cycle.
- ECOG performance status of 0-2
- Patients must not have active uncontrolled HIV, HBV, and HCV infections. Well-controlled infections on treatment will be allowed to participate in the trial.
- Patients with stable and asymptomatic brain metastasis.
- Adequate organ function - bone marrow, kidney, and liver.
Exclusion criteria
- Significant renal impairment requiring dialysis or hepatic impairment with end-stage liver disease.
- Participants with leptomeningeal disease.
- Participants with a recent diagnosis of heart failure and acute coronary disease within 3 months.
- Participants who are unable to receive immunotherapy with chemotherapy for induction will be excluded, or those immunotherapy was discontinued to manage immune-related adverse events
- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrolment.
- Patients with prior exposure to anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4) within 12 months of the study is not allowed.
Where
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations