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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
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 belowSelect...
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:Select...
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)
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 • NCT0200822736%
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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
Atezolizumab
2017
Completed Phase 3
~5850
Find a Location
Who is running the clinical trial?
Xcovery Holdings, Inc.Industry Sponsor
9 Previous Clinical Trials
607 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,612 Total Patients Enrolled
Xcovery Holding Company, LLCIndustry Sponsor
8 Previous Clinical Trials
519 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have untreated brain metastases or brain bleeding, and I haven't had preventive brain radiation.My high blood pressure has not been controlled with medication for over 3 weeks.I have not coughed up a significant amount of blood recently nor does my cancer invade major blood vessels.I haven't taken antibiotics in the last 2 weeks, except for prevention.I am 18 years old or older.You need to have a certain level of a type of white blood cell called neutrophils.I have not received a live flu vaccine within the last 4 weeks or during the study.I have not had severe infections or been hospitalized for them in the last 2 weeks.I do not have active tuberculosis.I agree to use birth control during and after the study and am not breastfeeding.I have active hepatitis B or had it in the past but it's resolved now.I've had 3-4 cycles of specific cancer treatment without my tumor growing and can start the study treatment within 6-8 weeks.I have not had a serious blood clot in the last 3 months.My blood clotting tests are within normal limits, or if on blood thinners, within the therapeutic range.I have an active autoimmune disease like lupus or rheumatoid arthritis.I am on a daily aspirin or similar blood thinner, but no more than 325 mg/day.Your liver enzymes (AST and ALT) are within a certain range, unless you have cancer that has spread to your liver.My blood tests for bone marrow and organ function are normal.I am on a stable dose of a non-Coumadin blood thinner.I have not had severe bleeding in my stomach or intestines in the last 3 months.I have not had a GI perforation or fistula, or risk factors for one, in the last 6 months.You have had allergic reactions to drugs similar to vorolanib or atezolizumab.I had cancer before, but I finished all treatments over 2 years ago and am now cancer-free.I am taking more than 10 mg/day of prednisone or its equivalent.I have small cell lung cancer treated only with specific initial drugs.I have not had any serious wounds, ulcers, or bone fractures in the last 28 days.I have not had major surgery in the last 28 days or minor surgery in the last 7 days.Your platelet count is at least 100,000 per microliter of blood.I haven't had a heart attack, stroke, or similar event in the last 6 months.I have a history of lung scarring or inflammation.I have a serious liver condition, such as severe hepatitis, cirrhosis, or fatty liver disease.I am fully active and can carry on all my pre-disease activities without restriction.Your hemoglobin level is at least 9.0 grams per deciliter.Your total bilirubin level should be less than 1.5 times the upper limit of normal.My urine protein levels are low enough for the trial.My kidney function is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Vorolanib + Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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