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Vorolanib + Atezolizumab for Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Daniel Morgensztern, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age.

Histologically or cytologically confirmed extensive stage small cell lung cancer without prior specific systemic therapy aside from induction with platinum, etoposide, and atezolizumab. Measurable disease is not required for eligibility.

Must not have

Hemoptysis (defined as bright red blood or ≥ ½ teaspoon) within 28 days prior to Cycle 1 Day 1 or with radiographic evidence of intratumor cavitation or radiologically documented evidence of major blood vessel invasion or encasement by cancer.

Severe infections within 2 weeks prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post start of treatment (up to 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding vorolanib to atezolizumab improves how long participants are cancer-free after standard chemotherapy.

Who is the study for?

Adults with extensive-stage small cell lung cancer who've had specific initial treatments without disease progression. They must have normal organ and bone marrow function, not be on certain blood thinners or antiplatelet drugs, and can't have uncontrolled high blood pressure or recent severe infections. Participants need to agree to use contraception and cannot be pregnant or breastfeeding.

What is being tested?

The trial is testing if adding vorolanib to atezolizumab extends the time patients remain cancer-free after standard chemotherapy. Patients will receive this combination as a maintenance therapy, which means it's used after initial treatment to help keep the cancer from coming back.

What are the potential side effects?

Potential side effects include typical reactions related to immune therapies such as fatigue, diarrhea, skin issues, potential liver inflammation, and increased risk of infection. Vorolanib may also cause hypertension and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have small cell lung cancer treated only with specific initial drugs.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My urine protein levels are low enough for the trial.

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My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not coughed up a significant amount of blood recently nor does my cancer invade major blood vessels.

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I have not had severe infections or been hospitalized for them in the last 2 weeks.

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I have not received a live flu vaccine within the last 4 weeks or during the study.

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I do not have active tuberculosis.

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I have not had a serious blood clot in the last 3 months.

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I have an active autoimmune disease like lupus or rheumatoid arthritis.

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I have not had severe bleeding in my stomach or intestines in the last 3 months.

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I am taking more than 10 mg/day of prednisone or its equivalent.

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I have not had any serious wounds, ulcers, or bone fractures in the last 28 days.

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I haven't had a heart attack, stroke, or similar event in the last 6 months.

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I have a history of lung scarring or inflammation.

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I have a serious liver condition, such as severe hepatitis, cirrhosis, or fatty liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post start of treatment (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post start of treatment (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post start of treatment (up to 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kaplan Meier Estimate of Progression-free Survival at 6 Months

Secondary study objectives

Overall Survival

Progression-free Survival

Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

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: Vorolanib + AtezolizumabExperimental Treatment2 Interventions

Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorolanib

2018

Completed Phase 2

~90

Atezolizumab

2016

Completed Phase 3

~5860