Clinical Trials /

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

NCT02514174

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 4

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Afatinib</span> Treatment for Patients With <span class="go-doc-concept go-doc-alteration">EGFR Mutation</span> Positive <span class="go-doc-concept go-doc-disease">NSCLC</span> Who Are Age 70 or Older

Title

  • Brief Title: Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
  • Official Title: A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
  • Clinical Trial IDs

    NCT ID: NCT02514174

    ORG ID: 1200.209

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    ErbB Receptors

    Trial Interventions

    Drug Synonyms Arms
    Afatinib Afatinib

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Afatinib Experimental afatinib starting at 40 mg daily dose Afatinib

    Eligibility Criteria

    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.

    Minimum Eligible Age: 70 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Occurrence of AEs leading to dose reduction of afatinib

    Secondary Outcome Measures

    Occurrence of CTCAE grade 3 or higher diarrhoea

    Occurrence of CTCAE grade 3 or higher rash/acne+ (+ represents grouped term)

    Occurence of CTCAE grade 3 or higher stomatitis+ (+ represents grouped term)

    Occurence of CTCAE grade 3 or higher paronychia+ (+ represents groupded term)

    Trial Keywords