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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.
 
ClinicalTrials.gov Identifier: NCT02514174
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
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
Allocation: N/A
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
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : April 25, 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. Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib [ Time Frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days ]
    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).


Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher [ Time Frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days ]

    Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher.

    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).


  2. Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher [ Time Frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days ]

    Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher.

    MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).


  3. Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher [ Time Frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days ]

    Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher.

    MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).


  4. Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher [ Time Frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days ]

    Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher.

    MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).


  5. Time to First Dose Reduction of Afatinib Caused by Adverse Events [ Time Frame: On-treatment period, up to 1057 days ]

    Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib.

    On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

    The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events.




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

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 ClinicalTrials.gov identifier (NCT number): NCT02514174


Locations
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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
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] February 15, 2018
Statistical Analysis Plan  [PDF] March 25, 2019

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02514174    
Other Study ID Numbers: 1200.209
First Posted: August 3, 2015    Key Record Dates
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020
Last Verified: March 2020
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action