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Study of Sacituzumab Govitecan with Immunotherapy for Extensive-Stage Small Cell Lung Cancer

This study is looking at a new way to treat extensive-stage small cell lung cancer (SCLC), which is cancer that has spread widely. Researchers want to see if combining sacituzumab govitecan with either atezolizumab or durvalumab can help control tumor growth. These medications are already approved for other cancers. You might be able to join if you are 18 or older and have extensive-stage SCLC confirmed by a doctor. The study will measure success by looking at changes in your tumor size and if new tumors appear. The current status of this study is unclear, and it plans to enroll about 35 participants.

Study design
This interventional study plans to enroll about 35 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive sacituzumab govitecan and immunotherapy every 21 days for up to 2 years or until the treatment stops working. You would have CT scans at 6 weeks for the first 6 cycles, then every 9-12 weeks, and an MRI brain scan every 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Disease control will be measured at 12 weeks from study enrollment.

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NCT07339059

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bindu R Potugari
~35 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Sacituzumab govitecanAtezolizumabDurvalumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Control
Measured over 12 weeks from study enrollment

Conditions

Small Cell Lung Cancer ( SCLC )
Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Who to contact

Bindu Potugari, MD
[email protected]
888-734-5322
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease Control12 weeks from study enrollment

    To evaluate the rate of disease control at 12 weeks for patients with extensive stage small cell lung cancer treated with Sacituzumab govitecan (SG) plus atezolizumab or durvalumab as maintenance therapy after induction treatment with chemotherapy and immunotherapy. Disease Control at 12 weeks is defined as a best response by RECIST 1.1 of CR, PR, non-CR, non-PR, or stable disease assessed by RECIST 1.1 and reported within 12 weeks (+/- 2 weeks) from the initiation of study therapy. Participants not known to have disease control at 12 weeks will be coded as lacking disease control.