Actively Recruiting
Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases
Led by Kamya Sankar · Updated on 2025-11-17
39
Participants Needed
3
Research Sites
176 weeks
Total Duration
On this page
Sponsors
K
Kamya Sankar
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign informed consent and comply with study requirements
- Histologically or cytologically confirmed extensive-stage small cell lung cancer with liver metastases at diagnosis
- Patients with EGFR mutant non-small cell lung cancer transformed to small cell lung cancer with liver metastases, chemotherapy and immunotherapy naive
- No prior treatment for extensive-stage small cell lung cancer, with exceptions for prior limited-stage treatment if treatment-free interval is at least six months
- Measurable disease by RECIST v1.1 criteria
- Asymptomatic patients with treated or untreated CNS lesions meeting specific criteria
- ECOG Performance Status of 0-2
- Adequate blood counts and organ function within 14 days before treatment
- For hepatitis C antibody positive patients, stable or treated hepatitis C with appropriate RNA testing
- Negative pregnancy test for women of childbearing potential
- Agreement to use contraception or abstain from heterosexual intercourse during and post-treatment as specified
- Agreement for men to use condoms or abstain and refrain from sperm donation during and after treatment as specified
You will not qualify if you...
- History of leptomeningeal disease
- History of significant blood clots within 3 months before treatment
- Uncontrolled hypertension above defined limits
- Tumor invading or touching major blood vessels
- Prior hypertensive crisis or encephalopathy
- Significant vascular disease within 6 months prior to randomization
- Recent history of coughing up blood
- Bleeding disorders without anticoagulation
- Recent use of certain blood thinners or unstable anticoagulation
- Recent core biopsy or minor surgery within 7 days before treatment
- History of gastrointestinal fistula or perforation within 6 months
- Clinical signs of bowel obstruction or need for parenteral nutrition
- Serious wounds, ulcers, or untreated bone fractures
- High levels of protein in urine
- Active or history of certain autoimmune diseases with exceptions
- History of specific lung diseases or active pneumonitis
- Active tuberculosis
- Significant recent cardiovascular disease
- Major surgery within 4 weeks before treatment
- Recent other malignancies with exceptions
- Severe infection or recent therapeutic antibiotics
- Prior organ or stem cell transplant
- Conditions contraindicating investigational drug use
- Known HIV infection with exceptions if controlled
- Known chronic hepatitis B
- Use of live vaccines near treatment period
- Recent systemic immunosuppressive medications with exceptions
- History of severe allergic reactions to antibodies or study drugs
- Known allergies to study drug components
- Use or planned use of traditional herbal medicines
- Treatment with investigational therapy within 28 days before study start
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Actively Recruiting
2
V.A. Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Amy Oppenheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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