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

NCT00111839 | Completed Phase 2 Results

• 2 other identifiers: EMD 72000-0312006-000899-32
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 58

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.

Conditions

Lung Cancer; Non Small Cell Lung Carcinoma

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response Assessed by Independent Review Committee

  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 Outcomes (4)

• Overall Survival (OS)

  Baseline up to PD or death due to any cause (up to approximately 3.5 years)

• Progression-Free Survival (PFS)

  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

  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)

  Baseline, Cycle 2 (Cycle length = 3 weeks)

Study Arms (3)

Pemetrexed Alone

ACTIVE COMPARATOR

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 Plus Matuzumab 800 mg per Week

EXPERIMENTAL

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; Drug: Matuzumab

Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks

EXPERIMENTAL

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; Drug: Matuzumab

Interventions

Pemetrexed DRUG

Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.

Pemetrexed Alone; Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks; Pemetrexed Plus Matuzumab 800 mg per Week

Matuzumab DRUG

Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.

Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks; Pemetrexed Plus Matuzumab 800 mg per Week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (58)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

University of Arkansas, Arkansas Cancer Research Center

Little Rock, Arkansas, 72205, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Cancer Center or Florida

Ocoee, Florida, 34761, United States

Location

Peachtree Hematology and Oncology

Atlanta, Georgia, 30309, United States

Location

Georgia Cancer Specialists

Tucker, Georgia, 30084, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Cancer Care Specialists of Central Illinois

Decatur, Illinois, 62256, United States

Location

Cancer Institute of Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

Location

Indiana Oncology Hematology Consultants

Indianapolis, Indiana, 46202, United States

Location

Hematology-Oncology of Indiana PC

Indianapolis, Indiana, 46260, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, 66210, United States

Location

Louisville Oncology

Louisville, Kentucky, 40202, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40402, United States

Location

Hematology-Oncology Clinic

Baton Rouge, Louisiana, 70808, United States

Location

Frederick Memorial Hospital

Frederick, Maryland, 21701, United States

Location

Tuffs-New England Medical Center

Boston, Massachusetts, 20111, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

West Michigan Regional Cancer and Blood Center

Free Soil, Michigan, 49411, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Missouri

Columbia, Missouri, 65203, United States

Location

Deaconess Billings Clinic

Billings, Montana, 59101, United States

Location

Nebraska Hematology-Oncology, PC

Lincoln, Nebraska, 68506, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Oncology

Albany, New York, 12208, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Presbyterian Hospital Cancer Center

Charlotte, North Carolina, 28204, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Dayton Oncology and Hematology

Kettering, Ohio, 45409, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Hematology & Oncology Associates of NEPA

Dunmore, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Mary Crowley Research Center

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Rainer Oncology Professional Services

Puyallup, Washington, 98372, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Research Site

Linz, Austria

Location

Research Site

Salzburg, Austria

Location

Research Site

Vienna, Austria

Location

Research Site

Wels, Austria

Location

Research Site

Cologne, Germany

Location

Research Site

Essen, Germany

Location

Research Site

Freiburg im Breisgau, Germany

Location

Research Site

Gauting, Germany

Location

Research Site

Göttingen, Germany

Location

Research Site

Großhansdorf, Germany

Location

Research Site

Halle, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Heidelberg, Germany

Location

Research Site

Mainz, Germany

Location

Research Site

München, Germany

Location

Research Site

Recklinghausen, Germany

Location

Related Publications (1)

• Schiller JH, von Pawel J, Schutt P, Ansari RH, Thomas M, Saleh M, McCroskey RD, Pfeifer W, Marsland TA, Kloecker GH, Sebastian M, Pirker R, Kurek R, Beadman C, Socinski MA. Pemetrexed with or without matuzumab as second-line treatment for patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1977-85. doi: 10.1097/JTO.0b013e3181f4a5c9.

  PMID: 20978446 RESULT

Related Links

• EudraCT results summary synopsis

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; matuzumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

For serious adverse events (SAEs), due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

496151725200

Study Officials

• Medical Responsible

  EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2005
• First Posted: May 27, 2005
• Study Start: May 31, 2005
• Primary Completion: July 31, 2007
• Study Completion: March 31, 2009
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-04

Locations

AU (4); US (42); DE (12)