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

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 Epidermal Growth Factor Receptor (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

  • ORG STUDY ID: GO28758
  • SECONDARY ID: 2013-000868-29
  • NCT ID: NCT01887886

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
erlotinibOnartuzumab + Erlotinib
onartuzumabOnartuzumab + Erlotinib
placeboPlacebo + Erlotinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Onartuzumab + ErlotinibExperimental
  • erlotinib
  • onartuzumab
Placebo + ErlotinibActive 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

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

        Exclusion Criteria:

          -  Prior exposure to agents targeting either the Hepatocyte Growth Factor (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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (investigator-assessed according to RECIST v1.1)
Time Frame:approximately 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Overall response rate
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Safety: Incidence of adverse events
Time Frame:approximately 3 years
Safety Issue:
Description:
Measure:Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame:Day 1 Cycles 1, 2 and 4
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Hoffmann-La Roche

Last Updated

November 2, 2016