Clinical Trials /

Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

NCT01746251

Description:

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients. In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
  • Official Title: Randomized Phase II Study Comparing Concise Versus Prolonged Afatinib as Adjuvant Therapy for Patients With Resected Stage I-III NSCLC With EGFR Mutation

Clinical Trial IDs

  • ORG STUDY ID: 12-504
  • NCT ID: NCT01746251

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
AfatinibConcise Afatinib

Purpose

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients. In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.

Detailed Description

      In order to determine if one is eligible to participate in this study they would be asked to
      undergo some screening tests or procedures. Many of these tests and procedures are likely to
      be part of regular cancer care and may be done even if it turns out that one does not take
      part in the research study. If the patient has had some of these tests or procedures
      recently, they may or may not have to be repeated. These tests and procedures include: a
      medical history, performance status, physical exam and vital signs including height and
      weight, an assessment of your tumor, routine blood tests, pregnancy test, electrocardiogram,
      echocardiogram and/or multigated acquisition scan. If these tests show that a patient is
      eligible to participate in the research study, they will begin the study treatment. If one
      does not meet the eligibility criteria, they will not be able to participate in this research
      study.

      Because no one knows which of the study options is best, the patients will be "randomized"
      into one of the study groups. They will take afatinib by mouth every day for either 3 months
      (short course) or for 2 years (long course). Randomization means that one is put into a group
      by chance. It is like flipping a coin. Neither the patient, nor the research doctor will
      choose what group the patient will be in. You will have a 50/50 chance of being placed in any
      group.

      Regardless of which study group one is put in, all patients will take Afatinib by mouth every
      day. The first cycle will last 28 days. All cycles after that will last 25-31 days. Patients
      will take their medication (tablets) by mouth once a day, at about the same time each day.
      They should take Afatinib with a glass of water. Afatinib treatment will continue until the
      assigned course is completed, or until there are side effects that cannot be tolerated, or
      one decides to stop study treatment, of if the lung cancer returns.

      Patients will be asked to come to the clinic at the following time points:

        -  Day 1 and 8 of Cycle 1

        -  Day 1 of Cycles 2, 3 and 4

        -  Off treatment visit-28 days after the last dose of study drug

      If one is assigned to the long course, one will also need to come in for clinic visits on Day
      1 of Cycles 7, 10, 13, 16, 19, 22 and 25. If one is assigned to the short course, one does
      not need to come in for these additional clinic visits.

      The following tests and procedures will be done to monitor for side effects of afatinib.

        -  Routine blood tests-about 2 tablespoons of blood

        -  Performance status

        -  Physical exam and vital signs, including height and weight

      The following tests and procedures will be done to monitor for recurrence of lung cancer.
      These visits are the same, regardless of whether one is taking a short course, or a long
      course of afatinib. There will be clinic visits once every 6 months for 3 years (months 7,
      13, 19, 25, 31, 37 and 49), and then one more visit 1 year later. The following tests and
      procedures will be done at these follow up visits: a CT scan of the chest, routine blood
      tests, performance status and a physical exam, including height and weight.
    

Trial Arms

NameTypeDescriptionInterventions
Concise AfatinibActive ComparatorAfatinib oral daily dose for 3 months
  • Afatinib
Prolonged AfatinibActive ComparatorAfatinib oral daily dose for 2 years
  • Afatinib

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation

          -  Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition
             staging criteria

          -  Surgical resection with curative intent was at least 6 months prior to enrollment

          -  At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  History of allergic reactions attributed to compounds of similar chemical composition
             to afatinib

          -  Prior exposure to EGFR tyrosine kinase inhibitor

          -  Evidence of clinically active interstitial lung disease

          -  Radiographic evidence of recurrent NSCLC prior to afatinib treatment

          -  Receipt of any experimental treatment within 30 days of start of treatment with
             afatinib until the end of treatment visit

          -  Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during
             treatment with afatinib

          -  Individuals with a history of a different malignancy (except: synchronous or
             metachronous primary non-small cell lung cancers of lower stage than the cancer for
             which adjuvant treatment is currently being prescribed; disease free for at least 3
             years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)

          -  HIV positive on combination antiretroviral therapy

          -  Uncontrolled intercurrent illness
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence-free survival
Time Frame:2 years
Safety Issue:
Description:The primary objective of this study is to demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival (RFS) compared to a concise adjuvant course in patients with resected stage I-III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.

Secondary Outcome Measures

Measure:Number of patients with adverse events
Time Frame:2 years
Safety Issue:
Description:To determine the safety and tolerability of adjuvant afatinib
Measure:Molecular genotype of recurrent cancers
Time Frame:2 years
Safety Issue:
Description:We aim to collect clinical data from patients with recurrent NSCLC after treatment with adjuvant afatinib, including molecular characteristics of recurrent cancer analyzed as part of routine care, and time to treatment failure for patients treated with alternative chemotherapies for recurrent lung cancer.
Measure:overall survival
Time Frame:2 years
Safety Issue:
Description:To estimate overall survival

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Massachusetts General Hospital

Trial Keywords

  • EGFR mutation
  • Resected

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