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

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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

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE August 3, 2015
Results First Submitted Date  ICMJE March 16, 2020
Results First Posted Date  ICMJE March 30, 2020
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE August 18, 2015
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Occurrence of AEs leading to dose reduction of afatinib [ Time Frame: One year after LPE ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Occurrence of CTCAE grade 3 or higher diarrhoea [ Time Frame: One year after LPE ]
  • Occurrence of CTCAE grade 3 or higher rash/acne+ (+ represents grouped term) [ Time Frame: One year after LPE ]
  • Occurence of CTCAE grade 3 or higher stomatitis+ (+ represents grouped term) [ Time Frame: One year after LPE ]
  • Occurence of CTCAE grade 3 or higher paronychia+ (+ represents groupded term) [ Time Frame: One year after LPE ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • ErbB Receptors
Intervention  ICMJE Drug: Afatinib
afatinib starting at 30 mg daily dose
Study Arms  ICMJE Experimental: Afatinib
afatinib starting at 30 mg daily dose
Intervention: Drug: Afatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
50
Actual Study Completion Date  ICMJE April 25, 2019
Actual Primary Completion Date March 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514174
Other Study ID Numbers  ICMJE 1200.209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP