A Study of Afatinib Treatment for Patients with Epidermal Growth Factor Receptor Mutation Positive Non-Small Cell Lung Cancer, Who Are Age 70 or Older

Overview

About this study

The purpose of this study is to describe the occurence of adverse events which lead to the reduction in dose of afatinib in elderly patients with non-small cell lung cancer, who have common EGFR (epidermal growth factor receptor) mutations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Pathologically or cytologically confirmed non-small cell lung cancer
  • Stage IV cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease
    • The staging is based on American Joint Commitee on Cancer Classification of Malignant Tumours 7th edition
  • Evidence of common EGFR mutation (Del 19 and/or L858R)
  • Age ≥ 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No prior systemic therapy for metastatic or recurrent non-small cell lung cancer
  • Further inclusion criteria apply

 

Exclusion Criteria

  • Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
  • 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
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Harshita Paripati, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.

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