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
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 15-006154
NCT ID: NCT02514174
Sponsor Protocol Number: 1200.209
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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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
- 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 us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Harshita Paripati, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office