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

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.

Study Start Date

November 2014

Estimated Completion Date

January 2017

Interventions

  • Drug: Erlotinib
  • Drug: Ficlatuzumab
  • Drug: placebo

Specialties

  • Internal Medicine: Pulmonology
  • Oncology: Lung/Thoracic Oncology
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Carcinoma
  • Non-Small-Cell Lung

Study ID

AVEO Pharmaceuticals, Inc. -- AV-299-14-206

Status

Unknown

Trial ID

NCT02318368

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

86

Sponsor

AVEO Pharmaceuticals, Inc.

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.
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (10)

    Study Location Distance Name Phone Email
    Queens Hospital Cancer Center - Jamaica, New York 45.0 miles Dr Mary Kemeny 718-883-3751 None
    Mount Sinai Beth Israel Comprehensive Cancer Center - New York, New York 51.4 miles Dr Benjamin Levy 212-367-0190 None
    Aultman Hospital - Canton, Ohio 427.9 miles Dr Raza Khan 330-363-1250 None
    Mayo Clinic - Rochester, Minnesota 997.5 miles Dr Julian Molina 855-776-0015 None
    Lakes Research - Miami Lakes, Florida 1,135.5 miles Dr Eloy Roman 786-362-5763 None
    Cancer Center of Acadiana - Lafayette, Louisiana 1,299.8 miles Dr Salman Malad 337-289-8656 None
    Huntsman Cancer Institute - Salt Lake City, Utah 2,001.3 miles Dr Akerley Wallace 801-585-0255 None
    UCSD - San Diego, California 2,471.8 miles Dr Lyudmila Bazenova 858-246-1093 None
    UCSF Fresno - Fresno, California 2,495.0 miles Dr Viola Zhu 559-256-9680 None
    Kaiser Permanente Hawaii - Honolulu, Hawaii 5,002.7 miles Dr Jennifer Carney 808-432-4689 None

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