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Monoclonal Antibodies

Bevacizumab + Chemoimmunotherapy + Atezolizumab for Small Cell Lung Cancer (BELIEVE Trial)

Ann Arbor, MI
Phase 2
Recruiting
Led By Kamya Sankar, MD
Research Sponsored by Kamya Sankar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
ECOG Performance Status of 0-2
Must not have
Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
History of pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose until death from any cause, assessed up to approximately 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if adding bevacizumab to atezolizumab and chemotherapy can help patients with ES-SCLC and liver metastases live longer without cancer progression.

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Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer (ES-SCLC) that has spread to the liver. They should not have had prior treatment for ES-SCLC, be in a stable condition (ECOG 0-2), and able to follow study procedures. Women must use birth control, and men agree to use condoms. People with certain health conditions or who've had specific treatments recently are excluded.Check my eligibility
What is being tested?
The trial tests if adding Bevacizumab to Atezolizumab plus chemotherapy improves how long patients with ES-SCLC and liver metastases live without their cancer getting worse. It includes an induction phase of all drugs for four cycles, followed by maintenance therapy up to 12 months or until side effects become too severe or the disease progresses.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding issues like coughing up blood, increased risk of infections due to immune system suppression, gastrointestinal complications such as perforation or fistula formation, allergic reactions, proteinuria (protein in urine), and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My EGFR mutant lung cancer has changed to small cell type and spread to my liver, and I haven't had chemotherapy or immunotherapy.
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I can take care of myself and am up and about more than half of my waking hours.
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My small cell lung cancer is confirmed by tests and has spread to my brain.
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I agree to not have unprotected sex or donate sperm.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not need IV fluids, feeding tubes, or have blockages in my digestive system.
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I have had lung scarring, organizing pneumonia, or signs of lung inflammation.
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I am HIV positive.
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I have had cancer spread to the lining of my brain and spinal cord.
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I have not had a severe infection in the last 4 weeks.
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My high blood pressure is not well-controlled.
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I am using or plan to use herbal medicines.
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I am currently taking or have recently taken certain medications.
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My cancer is growing into or very close to major blood vessels.
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I have active tuberculosis.
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I have chronic hepatitis B.
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I have a serious wound or bone fracture that hasn't healed.
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I have had a severe hypertension crisis or brain disorder.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose until death from any cause, assessed up to approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose until death from any cause, assessed up to approximately 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6- month Progression Free Survival (PFS) rate
Secondary study objectives
Incidence of adverse events
Objective Response Rate
Overall Survival (OS)
+1 more
Other study objectives
Tissue and blood based biomarkers

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
vitreous syneresis
9%
posterior capsule opacification
4%
cranial nerve VI palsy
4%
colon cancer
4%
pneumonia
4%
pyelonephritis
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment1 Intervention
1. Induction (ABCE): Atezolizumab 1200 mg, Bevacizumab 15 mg/kg, Carboplatin AUC5, Etoposide 100 mg/m2, given IV Q3weeks 2. Maintenance (AB): Atezolizumab 1200 mg and Bevacizumab 15 mg/kg given IV Q3weeks for 1 year, or until disease progression, or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Closest Location:University of Michigan· Ann Arbor, MI· 165 miles

Who is running the clinical trial?

University of MichiganOTHER
1,887 Previous Clinical Trials
6,462,324 Total Patients Enrolled
Kamya SankarLead Sponsor
Genentech, Inc.Industry Sponsor
1,576 Previous Clinical Trials
570,928 Total Patients Enrolled
VA Ann Arbor Healthcare SystemFED
18 Previous Clinical Trials
10,218 Total Patients Enrolled
Kamya Sankar, MDPrincipal InvestigatorCedars-Sinai Cancer

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05588388 — Phase 2
Lung Cancer Research Study Groups: Experimental Treatment
Lung Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05588388 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05588388 — Phase 2
~26 spots leftby Dec 2026