Clinical trial NCT02514174: Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
ErbB Receptors
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
timeFrame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary outcomes:
measure: Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher
timeFrame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
measure: Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher
timeFrame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
measure: Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher
timeFrame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
measure: Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
timeFrame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
measure: Time to First Dose Reduction of Afatinib Caused by Adverse Events
timeFrame: On-treatment period, up to 1057 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic-Arizona
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: Baystate Health D'Amour Center for Cancer Care
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: