Sacituzumab govitecan with atezolizumab or durvalumab as maintenance 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

This study tests whether adding sacituzumab govitecan to ongoing atezolizumab or durvalumab can better control tumors in adults with extensive-stage small cell lung cancer after initial platinum-based chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Drugs / interventions: atezolizumab, Durvalumab, chemotherapy, immunotherapy, radiation, sacituzumab, Sacituzimab, pembrolizumab
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT07339059 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial gives adults with extensive-stage SCLC sacituzumab govitecan every 21 days together with either atezolizumab or durvalumab as maintenance therapy for up to two years or until the treatment stops working. Effectiveness will be measured by changes in tumor size and the appearance of new tumors on scheduled CT scans and brain MRIs. Participants will have CT scans at six weeks for the first six cycles then every 9–12 weeks and brain MRI every 12 weeks, and may provide optional tissue and blood samples for correlative studies. The goal is to extend the duration of disease control after initial platinum‑etoposide plus immunotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults with extensive-stage SCLC who have not progressed after 4–6 cycles of platinum‑etoposide plus atezolizumab or durvalumab, have ECOG 0–2, and adequate organ function.

Not a fit: Patients whose disease has progressed on restaging scans after chemo‑immunotherapy, those with significant organ dysfunction (for example severe renal impairment), or those with uncontrolled active infections are unlikely to benefit.

Why it matters

Potential benefit: If successful, this regimen could prolong the period of disease control and potentially extend overall survival for patients who responded to initial chemo‑immunotherapy.

How similar studies have performed: Sacituzumab govitecan combined with immune agents has shown promising activity in breast cancer, while adding atezolizumab or durvalumab to chemotherapy in ES‑SCLC produced only modest survival gains, so this specific combination is promising but not yet proven in SCLC.

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.

Where this trial is running

Detroit, Michigan

• Henry Ford Cancer- Detroit — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Bindu Potugari, MD

Conditions Small Cell Lung Cancer; Extensive Stage Small Cell Lung Cancer; atezolizumab; durvalumab; sactizumab govetican; small cell lung cancer; sclc; es-sclc