Clinical Trials /

Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer

NCT02018523

Description:

The purpose of this study is to investigate the safety and efficacy of maintenance therapy with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) after first line chemotherapy. Investigators expect this treatment approach will delay disease progression by boosting the patient's anti-tumor immune response. Investigators hypothesize that 10 mg/day of lenalidomide can be administered safely as maintenance therapy and improve progression free survival time.

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

Terminated

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Lenalidomide</span> Maintenance Therapy in Stage IIIB/IV Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer
  • Official Title: A Pilot Study of Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer After First-line Chemotherapy
  • Clinical Trial IDs

    NCT ID: NCT02018523

    ORG ID: H-32774

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    Trial Interventions

    Drug Synonyms Arms
    Lenalidomide Revlimid Lenalidomide

    Trial Purpose

    The purpose of this study is to investigate the safety and efficacy of maintenance therapy
    with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer
    (NSCLC) after first line chemotherapy. Investigators expect this treatment approach will
    delay disease progression by boosting the patient's anti-tumor immune response.
    Investigators hypothesize that 10 mg/day of lenalidomide can be administered safely as
    maintenance therapy and improve progression free survival time.

    Detailed Description

    For patients with stage IIIB/IV non-small cell lung cancer, who did not progress after first
    line chemotherapy, lenalidomide 10mg/day orally will be administered as maintenance therapy
    until disease progression or death.

    Trial Arms

    Name Type Description Interventions
    Lenalidomide Experimental Oral lenalidomide 10 mg daily until disease progression Lenalidomide

    Eligibility Criteria

    Inclusion Criteria:

    - Patients must have histologically or cytologically confirmed stage IIIB or stage IV
    NSCLC with measurable disease at initial presentation prior to chemotherapy.

    - Patients must have had a complete response (CR), partial response (PR) or stable
    disease (SD) from first-line chemotherapy. Tumor response will be assessed by RECIST
    criteria version 1.1

    - Patients must have fully recovered from the acute toxic effects of all prior
    chemotherapy, or radiotherapy before entering this study.

    - Patients must be 18 years of age or older.

    - ECOG performance status < 2 (Karnofsky > 70%)

    - Organ Functions: Patients must have normal organ and marrow function as defined
    below: leukocytes >/= 3,000/uL; absolute neutrophil count >/=1,500/uL; hemoglobin
    >/=8g/dl; platelets >/=100,000/uL; total bilirubin </=1/5X institutional upper limit
    of normal (IULN); AST(SGOT) and ALT (SGPT) </=1.5X IULN; creatinine clearance ./+60
    mL/min/1.73 m2 for patients with creatinine levels > institutional normal

    - All study participants must be registered into the mandatory RevAssist program, and
    be willing and able to comply with the requirements of RevAssist.

    - Females of childbearing potential (FCBP) must have a negative serum or uring
    pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days before
    starting treatment and again within 24 hours prior to initiation of lenalidomide for
    Day 1.

    - All patients must be counseled about pregnancy precautions, risks of fetal exposure
    and other risks. The counseling must be done before the initiation of the study and
    every 28 days before the study drug is dispensed to the subject. FCBP must either
    commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
    methods of birth control, one highly effective method and one additional effective
    method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
    FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex
    condom during sexual contact with a FCBP even if they have had a successful
    vasectomy.

    - Able to take aspirin (81 mg) daily as prophylactic anticoagulation (patient's
    intolerant to ASA may use warfarin or low molecular weight heparin)

    - Able to understand and willing to sign an written informed consent document.

    - Life expectancy >/= 12 weeks

    Exclusion Criteria:

    - Concomitant Medications: no other anti-cancer therapy; no other investigational
    agents; no systemic steroids or other immunosuppressive drugs and may not have
    received systemic steroids within 30 days of study registration.

    - Patients with untreated brain metastasis, or with treated brain metastasis but
    requiring steroids

    - Patients with known EGFR mutation or EML-ALK fusion gene and with stage IV disease

    - History of allergic reactions attributed to compounds of similar chemical or
    biological composition to lenalidomide or thalidomide

    - The development of erythema nodosum if characterized by a desquamating rash while
    taking thalidomide or similar drugs

    - Uncontrolled inter-current illness including, but not limited to, ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, autoimmune disease or psychiatric illness/social situations that would
    limit compliance with study requirements

    - Pregnant women are excluded from this study because lenalidomide has the potential
    for teratogenic or abortifacient effects. Because there is an unknown but potential
    risk for adverse events in nursing infants secondary to treatment of the mother with
    lenalidomide, breastfeeding should be discontinued if the mother is treated with
    lenalidomide

    - Known sera-positive for or active viral infection with human immunodeficiency virus
    (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
    seropositive because of hepatitis B virus vaccine are eligible.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression free survival

    Secondary Outcome Measures

    Number of participants with adverse events

    Change in circulating immune cells

    Change in circulating immune cells

    Change in circulating immune cells

    Change in circulating immune cells

    Change in circulating immune cells

    Change in circulating immune cells

    Trial Keywords

    Carcinoma, Non-Small-Cell Lung

    Stage 3B/4

    Maintenance Therapy

    Lenalidomide