Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
- Registration Number
- NCT02514174
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Afatinib Afatinib afatinib starting at 30 mg daily dose
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib 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
Name Time Method Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher 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 = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher 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 = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher 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 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 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.
Trial Locations
- Locations (10)
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
Baystate Health D'Amour Center for Cancer Care
🇺🇸Springfield, Massachusetts, United States
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Mayo Clinic-Arizona
🇺🇸Scottsdale, Arizona, United States
Los Angeles Hematology Oncology Medical Group
🇺🇸Los Angeles, California, United States
City of Hope
🇺🇸Duarte, California, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States