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Tyrosine Kinase Inhibitor
Afatinib +/− Cetuximab for Non-Small Cell Lung Cancer
Phase 2 & 3
Waitlist Available
Led By Sarah Goldberg
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying afatinib dimaleate with or without cetuximab to treat patients with non-small cell lung cancer that has EGFR mutations.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that tests positive for EGFR mutations. Participants must be able to take oral medication, have not had major surgery recently, and cannot have active hepatitis B/C or HIV. They should not have significant heart issues, gastrointestinal disorders causing diarrhea, or a history of allergic reactions to similar drugs. Women who are pregnant or nursing are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of afatinib dimaleate alone versus combined with cetuximab in treating NSCLC with EGFR mutations. Afatinib blocks enzymes needed for tumor growth while cetuximab targets certain cells to inhibit tumor expansion.See study design
What are the potential side effects?
Potential side effects include diarrhea, rash, mouth sores from afatinib; and skin reactions, low magnesium levels, and infusion-related reactions from cetuximab. Side effects can vary based on individual patient health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year Overall Survival Rate
Progression-Free Survival
Secondary outcome measures
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Response Rates
Time to Treatment Discontinuation
+1 moreOther outcome measures
Change in Copy Number Alterations in MET, EGFR, and HER2, Analyzed Using Fluorescence in Situ Hybridization
Change in the Ratio of Sensitizing EGFR Mutation to EGFR T790 Mutation
EGFR Immunohistochemistry H-score
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (afatinib dimaleate, cetuximab)Experimental Treatment3 Interventions
Patients receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (afatinib dimaleate)Active Control2 Interventions
Patients receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afatinib Dimaleate
2015
Completed Phase 1
~60
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,996 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,637 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,979 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has specific EGFR mutations and was tested in a certified lab.I've had a brain scan in the last 42 days showing no symptoms of brain cancer.Your hemoglobin level is 9 grams per deciliter or higher.My lung cancer is at stage IV or has come back.My cancer can be seen on scans taken within the last 42 days.I don't have any serious illnesses that could affect my safety or interfere with the study.I agree to provide tissue and blood samples for research.You must have a certain number of a type of white blood cells called neutrophils in your blood.Your platelet count is at least 75,000 per microliter.Your total bilirubin level in your blood must be less than 1.5 times the upper limit of normal.My kidney function is within the normal range.I can take medicine by mouth.I do not have active hepatitis B or C, and I am not HIV positive.I haven't had major surgery in the last 28 days and don't plan to during treatment.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 3 years.I have no allergies to afatinib or cetuximab or similar drugs.I haven't had systemic cancer treatments for my advanced disease, but past local or early-stage treatments are okay if it's been over a year.I am not pregnant or nursing and will use effective birth control if of reproductive age.I don't have serious heart problems and my heart's pumping ability is good.I do not have any active lung diseases other than my cancer.Your AST and ALT levels in the blood are not too high, unless you have liver cancer that has spread.I do not have major GI issues like Crohn's disease causing diarrhea.I can take care of myself and am up and about more than 50% of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (afatinib dimaleate, cetuximab)
- Group 2: Arm II (afatinib dimaleate)
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.
Frequently Asked Questions
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