Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
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
1 other identifier
interventional
25
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2015
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 3, 2015
CompletedStudy Start
First participant enrolled
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2019
CompletedResults Posted
Study results publicly available
March 30, 2020
CompletedMarch 30, 2020
March 1, 2020
3.6 years
July 17, 2015
March 16, 2020
March 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction 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 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).
On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary Outcomes (5)
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 = 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 = 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 = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events
On-treatment period, up to 1057 days
Study Arms (1)
Afatinib
EXPERIMENTALafatinib starting at 30 mg daily dose
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo Clinic-Arizona
Scottsdale, Arizona, 85250, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
City of Hope
Duarte, California, 91010, United States
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
University of Miami
Miami, Florida, 33136, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Baystate Health D'Amour Center for Cancer Care
Springfield, Massachusetts, 01199, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitation: Protocol was amended on 15-February-2018 to reduce total sample size from n=50 participants to n=25 participants due to slow enrollment.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
August 3, 2015
Study Start
August 18, 2015
Primary Completion
March 28, 2019
Study Completion
April 25, 2019
Last Updated
March 30, 2020
Results First Posted
March 30, 2020
Record last verified: 2020-03