Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 30, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- Boehringer Ingelheim
- Interventions being studied
- Drug: Afatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic-ArizonaScottsdale, Arizona
- Pacific Cancer Medical Center, Inc.Anaheim, California
- City of HopeDuarte, California
- Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.Fountain Valley, California
- Los Angeles Hematology Oncology Medical GroupLos Angeles, California
- University of MiamiMiami, Florida
- Ingalls Memorial HospitalHarvey, Illinois
- Baystate Health D'Amour Center for Cancer CareSpringfield, Massachusetts
- Montefiore Medical CenterThe Bronx, New York
- Lankenau Medical CenterWynnewood, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 30, 2020. Always confirm current availability with the study team.