Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

April 5, 2018 updated by: EMD Serono

Randomized, Phase II, Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine

This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Germany
      • Essen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Gauting, Germany
        • Research Site
      • Grosshansdorf, Germany
        • Research Site
      • Göttingen, Germany
        • Research Site
      • Halle /Saale, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Recklinghausen, Germany
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas, Arkansas Cancer Research Center
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California/Norris Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network
      • Ocoee, Florida, United States, 34761
        • Cancer Center or Florida
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Peachtree Hematology and Oncology
      • Tucker, Georgia, United States, 30084
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Decatur, Illinois, United States, 62256
        • Cancer Care Specialists of Central Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Cancer Institute of Alexian Brothers
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Oncology Hematology Consultants
      • Indianapolis, Indiana, United States, 46260
        • Hematology-Oncology of Indiana PC
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Louisville Oncology
      • Louisville, Kentucky, United States, 40402
        • James Graham Brown Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Hematology-Oncology Clinic
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 20111
        • Tuffs-New England Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
      • Free Soil, Michigan, United States, 49411
        • West Michigan Regional Cancer and Blood Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology, PC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology And Hematology
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 19107
        • Hematology & Oncology Associates of NEPA
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Research Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Puyallup, Washington, United States, 98372
        • Rainer Oncology Professional Services
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent provided prior to any screening procedure
  • Male or female, greater than (>) 18 years of age
  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Demonstrated PD on or after first-line chemotherapy for Stage IIIB/IV disease. The first-line therapy must consist of platinum-based regimens in combination with taxanes, gemcitabine or vinorelbine. Stage IIIB/IV participants must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural effusion can be effectively drained prior to admission into the study
  • A chemotherapy-free interval of at least 3 weeks between the end of first-line chemotherapy and start of study treatment
  • At least 1 measurable lesion according to the modified World Health Organization (WHO) criteria
  • Archived tissue or cytologic sample available for the determination of epidermal growth factor receptor (EGFR) expression
  • Eastern cooperative oncology group (ECOG) performance status 0-1
  • Life expectancy >12 weeks
  • Adequate baseline organ functions, defined as: Serum creatinine less than or equal to (≤)1.5*upper limit of normal (ULN). In case of borderline values for serum creatinine, creatinine clearance must be greater than or equal to (≥) 45 millimeters per minute (mL/min); Total bilirubin <1.5*ULN; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5*ULN (participants with liver metastases should have ALT/AST <5*ULN.); Absolute neutrophil count ≥1500per cubic millimeter(mm^3); Platelet count ≥100000/mm^3; Hemoglobin level ≥10 grams per deciliter
  • If procreative potential (male or female), willingness to use effective contraceptive methods for the duration of treatment and continuing for 2 months after the last dose. Participants of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea ≥12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

  • Radiotherapy or major surgery within 30 days prior to the start of study treatment
  • Prior treatment with an EGFR-directed therapy or with EGFR signal transduction inhibitors
  • Prior treatment with pemetrexed
  • Pregnant (confirmed by beta-human chorionic gonadotropin [β-HCG]) or lactating female
  • Weight loss >10% within 12 weeks prior to the start of study treatment
  • Documented or symptomatic brain metastases or leptomeningeal disease
  • Myocardial infarction within 6 months prior to the start of study treatment, uncontrolled congestive heart failure, or any current New York Heart Association Grade III or IV cardiovascular disorder despite treatment
  • Presence of a Grade ≥2 preexisting skin disorder (except for alopecia)
  • Previous diagnosis of autoimmune disease with significant organ involvement
  • Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • Any significant disease that, in the Investigator's opinion, should exclude the participant from the study
  • History of significant neurologic or psychiatric disorder (for example, dementia, seizures, or bipolar disorder)
  • History of drug abuse within 6 months prior to the start of study treatment
  • Known conditions that require concurrent treatment with a nonpermitted drug
  • Presence of a contraindication to the study treatment(s) according to the current Investigator's Brochure (IB) for matuzumab and the labeling for pemetrexed
  • Known hypersensitivity to the study treatment or any of its components
  • Participation in another clinical study within 30 days prior to the start of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pemetrexed Alone
Participants will receive pemetrexed 50 milligrams per square meter (mg/m^2) intravenous (IV) infusion every 3 weeks until disease progression (PD) or the occurrence of unacceptable toxicity.
Drug: Pemetrexed
Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
Experimental: Pemetrexed Plus Matuzumab 800 mg per Week
Participants will receive pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 milligrams (mg) IV infusion once every week. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Drug: Pemetrexed
Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
Drug: Matuzumab
Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.
Experimental: Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Participants will receive pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Drug: Pemetrexed
Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
Drug: Matuzumab
Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Objective Response Assessed by Independent Review Committee
Time Frame: Baseline up to PD or death due to any cause (up to approximately 2 years)
Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. Complete response: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.
Baseline up to PD or death due to any cause (up to approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to PD or death due to any cause (up to approximately 3.5 years)
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
Baseline up to PD or death due to any cause (up to approximately 3.5 years)
Progression-Free Survival (PFS)
Time Frame: Baseline up to PD or death due to any cause (up to approximately 3.5 years)
PFS was defined as the time from randomization to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.
Baseline up to PD or death due to any cause (up to approximately 3.5 years)
Duration of Objective Response Assessed by Independent Review Committee
Time Frame: From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)
Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.
From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)
Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)
Time Frame: Baseline, Cycle 2 (Cycle length = 3 weeks)
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain] and 3 items were global items (symptom distress, interference with activity level, and global QoL). The global QoL item scores are reported here. The total global QoL item score ranged from 0 (worse QoL) to 100 (best QoL).
Baseline, Cycle 2 (Cycle length = 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Investigators

  • Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2005

Primary Completion (Actual)

July 31, 2007

Study Completion (Actual)

March 31, 2009

Study Registration Dates

First Submitted

May 26, 2005

First Submitted That Met QC Criteria

May 26, 2005

First Posted (Estimate)

May 27, 2005

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMD 72000-031
  • 2006-000899-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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