Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases
Eligible age
All ages
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
This clinical trial aims to assess whether the addition of bevacizumab to atezolizumab and chemotherapy can improve response to treatment and progression-free survival in patients with extensive-stage small cell lung cancer (ES-SCLC) with liver metastases. The main questions it aims to answer are: * In patients with ES-SCLC with liver metastases, can bevacizumab in combination with atezolizumab and chemotherapy prolong the length of time that the cancer does not progress? * Is bevacizumab safe and tolerable when combined with atezolizumab and chemotherapy in patients with ES-SCLC and liver metastases? The study treatment includes two phases: * Induction phase: bevacizumab will be administered in combination with atezolizumab and chemotherapy on a 21-day cycle for four cycles. * Maintenance: atezolizumab and bevacizumab will be administered every 21 days for up to 12 months, or until unacceptable toxicity or disease progression. Participants will undergo blood tests every 3 weeks and tumor assessments every 6 weeks.
Sponsor: Kamya Sankar
You may qualify if…
- ✓ Ability for subject to sign informed consent form and ability for subject to comply with the requirements of the study.
- ✓ Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group staging system), and radiographic confirmation of LM at diagnosis.
- ✓ Patients with history of EGFR mutant non-small cell lung cancer with histologically confirmed transformation to small cell lung cancer with presence of liver metastases, who are chemotherapy and immunotherapy naïve are eligible.
- ✓ No prior treatment for ES-SCLC. Note: patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least six months since the last chemotherapy, radiotherapy or chemoradiotherapy cycle prior to diagnosis of ES-SCLC
- ✓ Measurable disease per RECIST v1.1
- ✓ Asymptomatic patients with treated or untreated CNS lesions are eligible if there is no progression between completion of CNS-directed therapy and screening radiographic study, and the following criteria are met:
- ✓ Metastases are limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, or medulla).
- ✓ Presence of measurable disease outside the CNS per RECIST v1.1.
You may not qualify if…
- ✕ History of leptomeningeal disease
- ✕ History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of protocol therapy.
- ✕ Inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg)
- ✕ Anti-hypertensive therapy to achieve these parameters is allowable.
- ✕ Evidence of tumor invading or abutting major blood vessels.
- ✕ Prior history of hypertensive crisis or encephalopathy
- ✕ Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
- ✕ History of hemoptysis (≥one-half teaspoon of bright red blood per episode) within 1 month prior to study enrollment
Where it's recruiting
Los Angeles
Ann Arbor
Source: ClinicalTrials.gov · NCT05588388 · last updated 2025-11-17