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Monoclonal Antibodies

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

Phase 2
Waitlist Available
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
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
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

BELIEVE Trial 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.

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.

BELIEVE Trial 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.
Select...
I have not been treated for extensive-stage small cell lung cancer before.
Select...
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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My brain lesions are stable and I don't have symptoms.
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My recent blood and organ function tests are within normal ranges.

BELIEVE Trial 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

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

Side effects data

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

BELIEVE Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment1 Intervention
Induction (ABCE): Atezolizumab 1200 mg, Bevacizumab 15 mg/kg, Carboplatin AUC5, Etoposide 100 mg/m2, given IV Q3weeks 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
~5280

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,782 Previous Clinical Trials
6,364,618 Total Patients Enrolled
Kamya SankarLead Sponsor
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,641 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05588388 — Phase 2
Small Cell Lung Cancer Research Study Groups: Experimental Treatment
Small Cell 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions open for patients in this study?

"No, this particular study is not presently looking for participants. The clinicaltrials.gov website indicates that the study was first posted on February 1st 2023 and last updated on October 18th 2022. There are 2377 other trials active recruiting patients at the moment though."

Answered by AI

Has the FDA sanctioned this experimental procedure?

"There is some data supporting the safety of this experimental treatment, but none yet for efficacy. We gave it a score of 2."

Answered by AI
~26 spots leftby Sep 2026