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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:3/1/2019
Start Date:August 18, 2015
End Date:March 27, 2019

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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

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.


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.
We found this trial at
10
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Anaheim, California 92801
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Anaheim, CA
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Duarte, California 91010
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Fountain Valley, CA
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Harvey, IL
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Los Angeles, California 90017
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Los Angeles, CA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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3350 Main Street
Springfield, Massachusetts 01199
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Springfield, MA
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Wynnewood, Pennsylvania 19096
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Wynnewood, PA
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