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Tyrosine Kinase Inhibitor
Afatinib With Chemotherapy and Radiation for Lung Cancer
Phase 2
Waitlist Available
Led By Lecia V Sequist, MD MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed stage IIIA NSCLC
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing a drug called afatinib in patients with stage III non-small cell lung cancer and a specific genetic mutation. The drug is given before radiation and chemotherapy to shrink the tumor and make
Who is the study for?
This trial is for adults with stage IIIA non-small cell lung cancer (NSCLC) that has a specific change called an EGFR mutation. They should have measurable disease and be evaluated by specialized doctors to confirm they can undergo chemoradiation and possibly surgery.
What is being tested?
The study tests if adding Afatinib, a tyrosine kinase inhibitor, to the standard treatment of chemotherapy, radiation, and potentially surgery helps improve outcomes in NSCLC patients with EGFR mutations.
What are the potential side effects?
Afatinib may cause diarrhea, skin rashes, mouth sores, nail inflammation, decreased appetite or weight loss. Chemotherapy side effects include nausea, fatigue, hair loss; radiation might lead to skin irritation or difficulty swallowing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be at stage IIIA.
Select...
My cancer can be measured by tests.
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My lung cancer has an EGFR mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response Rate
Secondary study objectives
2 Year Progression-Free Survival
Evaluation of EGFR Mutation Status and other genotypes
Locoregional Tumor Control Rates
+2 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AfatinibExperimental Treatment5 Interventions
Afatinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Pemetrexed
FDA approved
Radiation
2003
Completed Phase 2
~780
Surgery
2000
Completed Phase 3
~2490
Afatinib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,770 Total Patients Enrolled
Lecia V Sequist, MD MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
366 Total Patients Enrolled