Purpose

Continuos 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.

Conditions

Eligibility

Eligible Ages
Over 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Pathologically or cytologically confirmed NSCLC
  2. Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. The staging is based on American Joint Commitee on Cancer (AJCC) Classification of Malignant Tumours (TNM) 7th edition (R12-4710)
  3. Evidence of common EGFR mutation (Del 19 and/or L858R)
  4. Age = 70 years
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01- 0787)
  6. No prior systemic therapy for metastatic or recurrent NSCLC.

Further inclusion criteria apply.

Exclusion Criteria

  1. Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
  2. Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
  3. Radiotherapy within 4 weeks prior to start of study treatment, except as follows:

i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.

4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study

5. 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).

6. 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.

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afatinib
afatinib starting at 30 mg daily dose
  • Drug: Afatinib
    afatinib starting at 30 mg daily dose

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467

More Details

NCT ID
NCT02514174
Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

Boehringer Ingelheim Call Center
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.