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Completed

NCT Number: NCT01887886

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib

Drug

150 mg orally daily

Onartuzumab

Drug

15 mg/kg IV every 3 weeks

Placebo

Drug

IV every 3 weeks

Primary outcomes

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

    Time frame: approximately 3 years

Secondary outcomes

  1. Overall survival

    Time frame: approximately 3 years

  2. Overall response rate

    Time frame: approximately 3 years

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

    Time frame: approximately 3 years

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

    Time frame: approximately 3 years

  5. Safety: Incidence of adverse events

    Time frame: approximately 3 years

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

    Time frame: Day 1 Cycles 1, 2 and 4

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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