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Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02514174
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung ErbB Receptors Drug: Afatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
Actual Study Start Date : August 18, 2015
Estimated Primary Completion Date : March 27, 2019
Estimated Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Afatinib
afatinib starting at 30 mg daily dose
Drug: Afatinib
afatinib starting at 30 mg daily dose

Primary Outcome Measures :
  1. Occurrence of AEs leading to dose reduction of afatinib [ Time Frame: One year after LPE ]

Secondary Outcome Measures :
  1. Occurrence of CTCAE grade 3 or higher diarrhoea [ Time Frame: One year after LPE ]
  2. Occurrence of CTCAE grade 3 or higher rash/acne+ (+ represents grouped term) [ Time Frame: One year after LPE ]
  3. Occurence of CTCAE grade 3 or higher stomatitis+ (+ represents grouped term) [ Time Frame: One year after LPE ]
  4. Occurence of CTCAE grade 3 or higher paronychia+ (+ represents grouped term) [ Time Frame: One year after LPE ]
  5. Time to first dose reduction of afatinib caused by AE's, defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AE's. [ Time Frame: One year after LPE ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th edition (R12-4710)
  • Evidence of common EGFR mutation (Del 19 and/or L858R)
  • Age >= 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
  • Further inclusion criteria apply.

Exclusion criteria:

  • Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
  • Prior systemic therapy for metastatic or recurrent NSCLC.
  • Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
  • Radiotherapy within 4 weeks prior to start of study treatment, except as follows:

    • Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or
    • Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
    • Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
    • Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
  • Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
  • Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02514174

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United States, Arizona
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85250
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
City of Hope
Duarte, California, United States, 91010
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States, 92708
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90017
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Massachusetts
Baystate Health D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02514174     History of Changes
Other Study ID Numbers: 1200.209
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action