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Monoclonal Antibodies

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

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.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of first dose until death from any cause, assessed up to approximately 48 months

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

52%

increased intraocular pressure

26%

worsening of cataract

15%

posterior capsule opacification

11%

vitreous syneresis

epiretinal membrane

vitreous hemorrhage

choroidal detachment

congestive heart failure

100%

80%

60%

40%

20%

Study treatment Arm

Ozurdex

Bevacizumab

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

0 / 17Eligibility criteria met