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Monoclonal Antibodies
Chemotherapy + Bevacizumab +/- Immunotherapy for Advanced Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Joseph Treat, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1
Must have normal organ and marrow function as defined
Must not have
Prior history of hypertensive crisis or hypertensive encephalopathy
Uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cirrhosis, or psychiatric illness/ social situations that would limit compliance with the study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12.5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is for never or light smokers with non-squamous non-small cell lung cancer that has spread and progressed after other treatments. It tests the addition of bevacizumab to carboplatin and paclitaxel to see if it improves survival.
Who is the study for?
Adults over 18 with stage IV non-squamous NSCLC who haven't had chemo, anti-VEGF, or immunotherapy (except certain TKIs for EGFR mutations). Must have measurable disease, adequate organ function, and no serious health issues like uncontrolled hypertension or recent bleeding. Smokers must have specific EGFR mutations; never-smokers can join without these mutations.
What is being tested?
This trial tests if adding Atezolizumab to Carboplatin+Pemetrexed+Bevacizumab improves outcomes in advanced lung cancer. Participants are randomly assigned to receive either the four-drug combo (Arm B) or just the three drugs without Atezolizumab (Arm A).
What are the potential side effects?
Possible side effects include high blood pressure from Bevacizumab, immune-related reactions from Atezolizumab such as inflammation of organs, fatigue, digestive problems from Pemetrexed and Carboplatin, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My organs and bone marrow are functioning normally.
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My tumor has an EGFR mutation in exon 19 or 21, or I have never smoked.
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My lung cancer is advanced and not of the squamous type.
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I am older than 18 years.
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I have at least one tumor that can be measured by CT or MRI.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a severe hypertension crisis or brain issues due to high blood pressure.
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I do not have any uncontrolled illnesses or infections that would affect my participation.
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I have been diagnosed with tuberculosis, whether active or inactive.
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I have tested positive for HIV/AIDS.
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I have pain from my cancer that isn't relieved by treatment.
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I have not received a live vaccine in the last 30 days.
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I am on a long-term blood thinner that is not aspirin.
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I have an autoimmune disease treated in the last year.
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My cancer has spread to the lining of my brain and spinal cord.
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I haven't had any serious wounds, ulcers, or untreated fractures in the last 28 days.
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I have not had major surgery in the last 28 days or minor surgery in the last 7 days.
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I have had a bone marrow or organ transplant in the past.
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I have never needed steroids for lung inflammation.
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My lung cancer has a specific genetic change.
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My blood pressure is high and not well managed.
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I do not need IV fluids, feeding tubes, or have blockages in my digestive system.
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I am not currently on any experimental drugs or cancer treatments.
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I have a chronic hepatitis B or C infection that is not cured.
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I have been diagnosed with squamous cell lung cancer.
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I have not had severe GI bleeding in the last 3 months.
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I have untreated brain metastases larger than 1 cm.
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I have severe liver disease, with symptoms like confusion or fluid in my abdomen.
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I take more than 10 mg of prednisolone or its equivalent daily.
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I have not coughed up blood in the last month and my cancer hasn't invaded major blood vessels.
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My scans show cancer has spread to the large blood vessels in my chest.
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I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12.5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival
Secondary study objectives
To compare the duration of response of Arm A to Arm B
To compare the overall response rate (ORR) of Arm A to Arm B
To perform a safety analysis in all treated subjects: NCI CTCAE v 5.0
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Arm A: Carboplatin + Pemetrexed + Bevacizumab + Atezolizumab Maintenance: Pemetrexed + Bevacizumab + Atezolizumab
Group II: Arm BActive Control1 Intervention
Arm B: Carboplatin + Pemetrexed + Bevacizumab Maintenance: Pemetrexed + Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arm A
2009
Completed Phase 2
~27390
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,256 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
7,283 Total Patients Enrolled
Joseph Treat, MDPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a severe hypertension crisis or brain issues due to high blood pressure.I do not have any uncontrolled illnesses or infections that would affect my participation.I am willing to switch from denosumab to a bisphosphonate for the study.I am fully active or can carry out light work.I have been diagnosed with tuberculosis, whether active or inactive.I have tested positive for HIV/AIDS.I have pain from my cancer that isn't relieved by treatment.I have not received a live vaccine in the last 30 days.I completed my curative therapy over a year ago.I am on a long-term blood thinner that is not aspirin.I am willing to use birth control if I can have children.Your blood calcium levels are higher than normal.My organs and bone marrow are functioning normally.I have an autoimmune disease treated in the last year.My cancer has spread to the lining of my brain and spinal cord.The amount of protein in your urine should be very low.I haven't had any serious wounds, ulcers, or untreated 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.I have had a bone marrow or organ transplant in the past.I haven't had chemotherapy, anti-VEGF, or immunotherapy, except for oral TKIs if I have EGFR mutation.My blood pressure is high and not well managed.Your lung lesions show clear cavities on imaging.My tumor has an EGFR mutation in exon 19 or 21, or I have never smoked.My lung cancer is advanced and not of the squamous type.I agree to use contraception since my partner can become pregnant.I have never needed steroids for lung inflammation.My lung cancer has a specific genetic change.My tumor has an EGFR mutation and I've been treated with TKIs.I do not need IV fluids, feeding tubes, or have blockages in my digestive system.I have recovered from side effects of previous treatments, except for nerve issues or hair loss.I am not currently on any experimental drugs or cancer treatments.I am older than 18 years.I have a chronic hepatitis B or C infection that is not cured.I have been diagnosed with squamous cell lung cancer.You have a condition that causes abnormal bleeding or blood clotting.I have not had severe GI bleeding in the last 3 months.I have untreated brain metastases larger than 1 cm.I have severe liver disease, with symptoms like confusion or fluid in my abdomen.I have not had a fistula or gut perforation in the last 6 months.You have air in your abdomen that can't be explained by a recent medical procedure.I have not had any blood clots in my arteries in the last 6 months.I have not had major blood vessel problems in the last 6 months.I take more than 10 mg of prednisolone or its equivalent daily.I can provide a biopsy sample for the study, or undergo a new biopsy if needed.I have not coughed up blood in the last month and my cancer hasn't invaded major blood vessels.I have at least one tumor that can be measured by CT or MRI.I have smoked more than 100 cigarettes in my life, but my tumor has an EGFR mutation.My scans show cancer has spread to the large blood vessels in my chest.I have had brain metastases treated and am not currently showing symptoms.I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.I have been on a stable dose of blood thinners for at least 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.