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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-18

Study Completion Date

2019-04-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung ErbB Receptors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afatinib

afatinib starting at 30 mg daily dose

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

afatinib starting at 30 mg daily dose

Interventions

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Afatinib

afatinib starting at 30 mg daily dose

Intervention Type DRUG

Eligibility Criteria

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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)

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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No