Clinical Trials /

A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

NCT02318368

Description:

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

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

Terminated

Phase:

Phase 2

Trial Eligibility

Document

A Phase 2, Multicenter, Study of Ficlatuzumab Plus <span class="go-doc-concept go-doc-intervention">Erlotinib</span> Versus <span class="go-doc-concept go-doc-intervention">Placebo</span> Plus <span class="go-doc-concept go-doc-intervention">Erlotinib</span> in Subjects Who Have Previously Untreated Metastatic, <span class="go-doc-concept go-doc-biomarker">EGFR</span>-<span class="go-doc-concept go-doc-keyword">mutated</span> Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> (NSCLC) and BDX004 Positive Label

Title

  • Brief Title: A Phase 2, Multicenter, Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label
  • Official Title: A Phase 2, Multicenter, Randomized, Double-blind Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label
  • Clinical Trial IDs

    NCT ID: NCT02318368

    ORG ID: AV-299-14-206

    Trial Conditions

    Non-small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Ficlatuzumab Ficlatuzumab plus erlotinib
    Erlotinib Ficlatuzumab plus erlotinib, Placebo plus erlotinib
    placebo Placebo plus erlotinib

    Trial Purpose

    Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and
    safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with
    previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Ficlatuzumab plus erlotinib Experimental 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle. Ficlatuzumab, Erlotinib
    Placebo plus erlotinib Active Comparator 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle. Erlotinib, placebo

    Eligibility Criteria

    Inclusion Criteria

    - Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC
    (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer
    staging criteria).

    - Measurable disease according to RECIST v.1.1.

    - An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.

    - BDX004 Positive Label.

    - Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or
    biologic therapy for metastatic NSCLC. Subjects may have previously been treated
    with postoperative adjuvant chemotherapy for early stage lung cancer or chemo
    radiotherapy for locally advanced disease provided this was completed at least 6
    months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of
    NSCLC.

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion
    Criteria

    - History of severe allergic or anaphylactic reactions or hypersensitivity to
    recombinant proteins or excipients in the investigational agent or erlotinib.

    - History of known brain metastases.

    - Prior treatment with any other investigational drug or biologic agent within 5 half
    lives prior to randomization, or any investigational device within 2 weeks prior to
    randomization.

    - Any unresolved toxicity from previous radiation therapy.

    - Significant cardiovascular disease, including:

    - Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left
    ventricular ejection fraction of less than 55%.

    - Cardiac failure New York Heart Association class III or IV.

    - Myocardial infarction, severe or unstable angina within 6 months prior to
    randomization.

    - History of serious ventricular arrhythmia (ie, ventricular tachycardia or
    ventricular fibrillation).

    - Significant thrombotic or embolic events within 3 months prior to randomization
    (significant thrombotic or embolic events include but are not limited to stroke
    or transient ischemic attack).

    - Any uncontrolled or severe cardiovascular disease.

    - History of prior malignancy within 3 years prior to randomization (except for
    adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or
    cervix, superficial bladder cancer, or early stage prostate cancer, without evidence
    of recurrence).

    - Radiographic evidence of interstitial lung disease.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.

    Secondary Outcome Measures

    Overall Survival as measured from the date of randomization to the date of death.

    Objective response rate is defined as a CR or PR according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.

    Disease control rate is defined as CR, PR, or SD at least 4 cycles (16 weeks) according to the RECIST v.1.1 recorded in the time period between randomization and disease progression or death to any cause.

    Safety and tolerability, as defined by number of AEs.

    PK parameters of ficlatuzumab and erlotinib will be calculated from serum and plasma levels in the blood over time.

    Trial Keywords