Clinical Trials /

A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

NCT01887886

Description:

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

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

Completed

Phase:

Phase 3

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Onartuzumab</span> in Combination With <span class="go-doc-concept go-doc-intervention">Erlotinib</span> in Patients With <span class="go-doc-concept go-doc-biomarker">MET</span>-Positive Stage IIIB or IV Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Carrying an Activating <span class="go-doc-concept go-doc-biomarker">EGFR</span> <span class="go-doc-concept go-doc-keyword">Mutation</span>

Title

  • Brief Title: A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating EGFR Mutation
  • Official Title: A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH ERLOTINIB AS FIRST-LINE TREATMENT FOR PATIENTS WITH MET-POSITIVE UNRESECTABLE STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER (NSCLC) CARRYING AN ACTIVATING EGFR MUTATION
  • Clinical Trial IDs

    NCT ID: NCT01887886

    ORG ID: GO28758

    NCI ID: 2013-000868-29

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    erlotinib Onartuzumab + Erlotinib, Placebo + Erlotinib
    onartuzumab Onartuzumab + Erlotinib
    placebo Placebo + Erlotinib

    Trial Purpose

    This multicenter, randomized, double-blind, placebo-controlled study will evalua te the
    safety and efficacy of onartuzumab in combination with erlotinib in patie nts with
    previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to
    carry and activating EGFR mutation and MET-positive. Patie nts will be randomized to receive
    either onartuzumab 15 mg/kg intravenously ever y 3 weeks in combination with erlotinib 150
    mg orally daily or placebo in combin ation with erlotinib. Anticipated time on study
    treatment is until disease progr ession or unacceptable toxicity occurs.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Onartuzumab + Erlotinib Experimental erlotinib, onartuzumab
    Placebo + Erlotinib Active Comparator erlotinib, placebo

    Eligibility Criteria

    Inclusion Criteria:

    - Adult patient, >/= 18 years of age

    - Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer
    (NSCLC)

    - No prior treatment for unresectable Stage IIIB or IV NSCLC

    - Measurable radiographic evidence of disease according to RECIST v1.1

    - ECOG performance status of 0 or 1

    Exclusion Criteria:

    - Prior exposure to agents targeting either the HGF or MET pathway

    - Exposure to an investigational or marketed agent that can act by EGFR inhibition

    - Pleural effusion, pericardial fluid, or ascites requiring drainage every other week
    or more frequently

    - Brain metastasis or spinal cord compression not definitively treated with surgery
    and/or radiation, or previously diagnosed and treated central nervous system (CNS)
    metastases or spinal cord compression without evidence of clinically stable disease
    for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on
    a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.

    - History of another malignancy in the previous 5 years, unless cured by surgery alone
    and continuously disease-free

    - Radiographically evident interstitial lung disease , concurrent infection, or a
    history of any of these conditions

    - Inadequate hematologic, biochemical, and organ function

    - Pregnant or lactating women

    - Life expectancy of < 12 weeks

    - Receipt of an investigational drug within 28 days prior to initiation of study
    treatment

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival (investigator-assessed according to RECIST v1.1)

    Secondary Outcome Measures

    Overall survival

    Overall response rate

    Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms

    Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires

    Safety: Incidence of adverse events

    Pharmacokinetics: Area under the concentration-time curve (AUC)

    Trial Keywords