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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests sacituzumab govitecan with atezolizumab or durvalumab to see if it can keep lung cancer from growing after the first treatment. It is for adults with small cell lung cancer that has spread widely, or nearby cancer that cannot be cured with radiation. The study will track tumor size and check for new tumors.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older and willing and able to agree to join the study.
  • Have small cell lung cancer confirmed by tissue or cell tests. It must have spread widely at diagnosis, or spread nearby and cannot be cured with radiation.
  • Have had at least 4 rounds of platinum chemotherapy plus etoposide and at least 2–3 rounds of atezolizumab or durvalumab.
  • Have no cancer growth on a CT scan of the chest, belly, and pelvis after 4–6 rounds of chemotherapy and immune treatment.
  • Can care for yourself and are up and about for at least half of your waking hours.
  • Have no active, uncontrolled HIV or hepatitis B or C infections. Well-controlled infections being treated are allowed.
  • If cancer has spread to the brain, it is stable and causes no symptoms.
  • Have bone marrow, kidneys, and a liver that work well enough.

Who can't join

  • Have kidney disease that needs dialysis, a treatment that filters the blood, or end-stage liver disease.
  • Have cancer in the tissue and fluid around the brain and spinal cord.
  • Have a recent heart failure diagnosis and sudden problems with blood flow to the heart within 3 months.
  • Could not receive immune treatment with the first chemotherapy, or stopped immune treatment because of immune-related side effects.
  • Have active, long-term bowel swelling, such as Crohn’s disease or ulcerative colitis, or had a hole in the stomach or bowel within 6 months of joining.
  • Received certain immune treatments within 12 months of the study, including drugs targeting PD-1, PD-L1, PD-L2, or other immune-cell targets such as CTLA-4.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MI