Clinical Trials /

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

NCT02695290

Description:

There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.

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

Terminated

Phase:

Phase 4

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Afatinib</span> in <span class="go-doc-concept go-doc-biomarker">EGFR</span>+<span class="go-doc-concept go-doc-disease">NSCLC</span> (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Title

  • Brief Title: Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)
  • Official Title: An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
  • Clinical Trial IDs

    NCT ID: NCT02695290

    ORG ID: 1200.208

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    ErbB Receptors

    Trial Interventions

    Drug Synonyms Arms
    Afatinib Afatinib

    Trial Purpose

    There is a medical need for improving treatment of poor performance status patients with
    EGFR driver mutations and documenting safety and tolerability of existing agents.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Afatinib Experimental Afatinib

    Eligibility Criteria

    Inclusion criteria:

    - Pathologically or cytologically confirmed NSCLC

    - Stage IV Cancer (includes cytologically proven pleural effusion or pericardial
    effusion) or recurrent disease. The staging is based on AJCC TNM classification of
    malignant tumors, 7th edition

    - Evidence of common EGFR activating mutations (Del 19 and/or L858R)

    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3

    - Adequate organ function, defined as all of the following:

    - Absolute neutrophil count (ANC) > 1500 / mm3

    - Platelet count >75,000 / mm3.

    - Baseline creatinine of < or = 1.5 g/dl or, if > 1.5, an estimated creatinine
    clearance of > 45 ml/min

    - Total Bilirubin < 1.5 times upper limit of institutional normal (ULN)

    - Aspartate amino transferase (AST) or alanine amino transferase (ALT) < three times
    ULN (if related to liver metastases < five times ULN)

    - Recovery from any previous therapy related toxicity to< or = Grade 1 at study entry
    (except for stable sensory neuropathy < or =Grade 2 and alopecia)

    - Life expectancy of at least three months

    - Written informed consent that is consistent with ICH-GCP guidelines

    - Age 18 or older

    Exclusion criteria:

    - Prior participation in an afatinib clinical study, even if not assigned to afatinib
    treatment

    - Prior systemic therapy for metastatic or recurrent NSCLC including prior treatment
    with EGFR targeting small molecules or antibodies. . Note: radiotherapy alone and
    adjuvant/neoadjuvant treatment is not counted as a line of therapy.

    - 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:

    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 (e.g SRS or
    SBRT) 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

    - Women of child-bearing potential (WOCBP) and men who are able to father a child, or
    use adequate contraception prior to study entry, for the duration of study
    participation and for at least 28 days after treatment has ended.

    - Presence of an active infection or with a fever > 38.5 C within 3 days of the first
    scheduled day of dosing

    - Known hypersensitivity to afatinib or the excipients of afatinib

    - Known pre-existing interstitial lung disease

    - Pathologically documented meningeal carcinomatosis (i.e. cytology (+) lumbar puncture
    ; radiology reports alone raising this as a possibility, in the absence of true
    symptomatology, would not constitute an exclusion)

    - Presence of brain or subdural metastases, unless local therapy has been completed and
    use of corticosteroids has been discontinued or the dose has been stable for at least
    4 weeks before starting study treatment. Any symptoms attributed to brain metastases
    must be stable for at least 4 weeks before starting study treatment (Pts post SRS can
    be enrolled earlier as long as their symptoms are stable or improved and they are off
    steroids)

    - Previous or concomitant malignancies at other sites, except effectively treated
    non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ
    or effectively treated malignancy that has been in remission for more than 2 years
    and is considered to be cured

    - History or presence of clinically relevant cardiovascular abnormalities such as
    uncontrolled hypertension, congestive heart failure NYHA classification of 3 or 4
    unstable angina or poorly controlled arrhythmia as determined by the investigator.
    Myocardial infarction within 6 months prior to treatment with afatinib.

    - Any history or presence of poorly controlled gastrointestinal disorders that could
    affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis,
    chronic diarrhoea, malabsorption)

    - Known or suspected active hepatitis B infection (defined as presence of HepB sAg and/
    or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or
    known HIV carrier

    - Any history of or concomitant condition that, in the opinion of the Investigator,
    would compromise the patient's ability to comply with the study or interfere with the
    evaluation of the safety and efficacy of the test drug

    - Treatment with any of the prohibited concomitant medications that cannot be stopped
    for the duration of trial participation

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Occurrence of Adverse Events (AEs) leading to dose reduction of afatinib

    Secondary Outcome Measures

    Occurrence of Common Toxicity Criteria Adverse Events (CTCAE) grade 3 or higher rash/acne+

    Occurrence of Common Toxicity Criteria Adverse Events (CTCAE) grade 3 or higher diarrhoea

    Occurrence of Common Toxicity Criteria Adverse Events (CTCAE) grade 3 or higher stomatitis+

    Occurrence of Common Toxicity Criteria Adverse Events (CTCAE) grade 3 or higher paronychia+

    Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.

    Trial Keywords