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Alkylating agents
Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Led By Heather A Wakelee
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (>= 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)
Patients must not have received hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to death, up to 10 years
Awards & highlights
Study Summary
This trial is comparing chemotherapy with or without bevacizumab in treating patients with early stage non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IB-IIIA non-small cell lung cancer removed by surgery. They must not have had hormonal or radiation therapy within the last 5 years, be recovered from surgery, and have good organ function and blood counts. Pregnant or breastfeeding women can't join, nor can those with recent serious health issues like heart failure or bleeding disorders. Participants need controlled blood pressure and no history of stroke or significant infections.Check my eligibility
What is being tested?
The study tests if adding Bevacizumab to chemotherapy after surgery improves outcomes in non-small cell lung cancer patients. It's a phase III trial comparing standard chemo alone versus chemo plus Bevacizumab, which may block tumor growth by inhibiting blood vessel formation.See study design
What are the potential side effects?
Chemotherapy side effects include nausea, fatigue, hair loss, increased infection risk, and possible damage to organs. Bevacizumab might cause high blood pressure, bleeding problems, slow wound healing and could increase the risk of developing clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.
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I haven't had hormone or radiation cancer treatments in the last 5 years.
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My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.
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I have had heart issues but have been symptom-free for over a year.
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I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.
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I am not pregnant or breastfeeding.
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My lung cancer is not of the squamous cell type.
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My kidney function is good, as shown by recent tests.
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I am not expecting to undergo any major surgeries during the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have never had a stroke or a mini-stroke.
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My urine protein levels are low enough for me to join.
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I haven't had major surgery, serious injuries, or biopsies recently.
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I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.
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I have never had bleeding disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to death, up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death, up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Disease-free Survival
Other outcome measures
Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.
To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB - IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.
Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (chemotherapy, bevacizumab)Experimental Treatment8 Interventions
Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.
Group II: Arm I (chemotherapy)Active Control7 Interventions
Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Pemetrexed Disodium
2015
Completed Phase 2
~280
Vinorelbine Tartrate
2010
Completed Phase 3
~670
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkNETWORK
394 Previous Clinical Trials
263,119 Total Patients Enrolled
Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
259,760 Total Patients Enrolled
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
116,487 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your SGPT (ALT) level in the blood is less than 5 times the upper limit of normal.I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.Your total bilirubin level must be less than or equal to 1.5 mg/dL.I haven't had hormone or radiation cancer treatments in the last 5 years.Your prothrombin time/international normalized ratio (INR) should be 1.5 or less.My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.I am not currently coughing up a significant amount of bright red blood.I have had heart issues but have been symptom-free for over a year.You must have a certain amount of a type of white blood cell called neutrophils in your blood.Women who could become pregnant must take a blood or urine test to make sure they are not pregnant before joining the study.I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.I am not pregnant or breastfeeding.My blood pressure is under control and below 150/90.I am on a stable blood thinner regimen or using it for DVT prevention.I am taking aspirin or NSAIDs daily, but not dipyridamole, ticlopine, clopidogrel, or cilostazol.I am eligible for pemetrexed/cisplatin therapy.My lung cancer is not of the squamous cell type.My kidney function is good, as shown by recent tests.My blood clotting time is within safe limits while on blood thinners.Your SGOT (AST) levels are not more than 5 times the upper limit of normal.I had lung surgery between 6 to 12 weeks ago and have recovered well.Your kidney function, as measured by a blood test for creatinine, is within a certain range.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.I am not expecting to undergo any major surgeries during the study.I am fully active or restricted in physically strenuous activity but can do light work.I have never had a stroke or a mini-stroke.My urine protein levels are low enough for me to join.I have never had chemotherapy, except possibly low-dose methotrexate for a non-cancer condition.I haven't had major surgery, serious injuries, or biopsies recently.I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.I have never had bleeding disorders.You are allergic to Chinese hamster ovary cell products or other similar medicines made from living cells.Your platelet count must be at least 100,000 per cubic millimeter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (chemotherapy)
- Group 2: Arm II (chemotherapy, bevacizumab)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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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