ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00111839
Recruitment Status : Completed
First Posted : May 27, 2005
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Non Small Cell Lung Carcinoma Drug: Pemetrexed Drug: Matuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 31, 2005
Actual Primary Completion Date : July 31, 2007
Actual Study Completion Date : March 31, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111839


  Show 58 Study Locations
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Additional Information:
Publications of Results:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00111839     History of Changes
Other Study ID Numbers: EMD 72000-031
2006-000899-32 ( EudraCT Number )
First Posted: May 27, 2005    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by EMD Serono:
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors