Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT00111839

Recruitment Status:

Completed

Sponsor:

EMD Serono

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There are 40 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT00111839

Recruitment Status:

Completed

Sponsor:


EMD Serono

How clear is this clinincal trial information?

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