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

Completed · Phase 2

Conditions studied: Lung Cancer, Non Small Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT00111839

Run by

EMD Serono

People needed

150

Starts

2005-05-31

Expected to finish

2009-03-31

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• University of Arkansas, Arkansas Cancer Research Center — Little Rock, Arkansas, United States
• University of Southern California/Norris Cancer Center — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Integrated Community Oncology Network — Jacksonville, Florida, United States
• Cancer Center or Florida — Ocoee, Florida, United States
• Peachtree Hematology and Oncology — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Tucker, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois — Chicago, Illinois, United States
• Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
• Cancer Institute of Alexian Brothers — Elk Grove Village, Illinois, United States
• Indiana Oncology Hematology Consultants — Indianapolis, Indiana, United States
• Hematology-Oncology of Indiana PC — Indianapolis, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Kansas City Cancer Center — Overland Park, Kansas, United States
• Louisville Oncology — Louisville, Kentucky, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Hematology-Oncology Clinic — Baton Rouge, Louisiana, United States
• Frederick Memorial Hospital — Frederick, Maryland, United States
• Tuffs-New England Medical Center — Boston, Massachusetts, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• West Michigan Regional Cancer and Blood Center — Free Soil, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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