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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
May have received curative intent therapy if completed greater than 1 year from entry into the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12.5 months
Awards & highlights

Study 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.Check my eligibility
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).See study design
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 below
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I am fully active or can carry out light work.
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I completed my curative therapy over a year ago.
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I am willing to use birth control if I can have children.
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My organs and bone marrow are functioning normally.
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I haven't had chemotherapy, anti-VEGF, or immunotherapy, except for oral TKIs if I have EGFR mutation.
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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 agree to use contraception since my partner can become pregnant.
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My tumor has an EGFR mutation and I've been treated with TKIs.
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I am older than 18 years.
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I can provide a biopsy sample for the study, or undergo a new biopsy if needed.
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I have at least one tumor that can be measured by CT or MRI.
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I have had brain metastases treated and am not currently showing symptoms.
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I have been on a stable dose of blood thinners for at least 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12.5 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
Progression free survival
Secondary outcome measures
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

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
227 Previous Clinical Trials
37,392 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,518 Total Patients Enrolled
Joseph Treat, MDPrincipal InvestigatorFox Chase Cancer Center

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03786692 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A, Arm B
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03786692 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03786692 — Phase 2

Frequently Asked Questions

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

Has Arm A received the regulatory greenlight from the FDA?

"Arm A was assessed as a 2 on the 1 to 3 scale due to there being evidence for safety, but not yet any data demonstrating efficacy."

Answered by AI

Is this research endeavor open to enrollees at the moment?

"Correct. Data accessible on clinicaltrials.gov verifies that this research endeavour, which began to accept applications on September 4th 2019 is actively enrolling 117 participants from 1 clinic site."

Answered by AI

What is the anticipated size of this trial's participant pool?

"Affirmative. According to clinicaltrials.gov, this particular medical trial is currently recruiting patients who meet the criteria. The experiment was initially posted on September 4th 2019 and has been recently updated as of February 8th 2022; 117 individuals across one site are needed for data collection purposes."

Answered by AI
~17 spots leftby Jan 2025