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.
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
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There are 40 Locations for this study
Tucson Arizona, 85715, United States
Little Rock Arkansas, 72205, United States
Los Angeles California, 90033, United States
San Diego California, 92123, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32256, United States
Ocoee Florida, 34761, United States
Atlanta Georgia, 30309, United States
Tucker Georgia, 30084, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62256, United States
Elk Grove Village Illinois, 60007, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
South Bend Indiana, 46601, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40402, United States
Baton Rouge Louisiana, 70808, United States
Frederick Maryland, 21701, United States
Boston Massachusetts, 20111, United States
Detroit Michigan, 48202, United States
Free Soil Michigan, 49411, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65203, United States
Billings Montana, 59101, United States
Lincoln Nebraska, 68506, United States
Lebanon New Hampshire, 03756, United States
Albany New York, 12208, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44195, United States
Kettering Ohio, 45409, United States
Portland Oregon, 97213, United States
Dunmore Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19107, United States
Dallas Texas, 75246, United States
Tyler Texas, 75702, United States
Puyallup Washington, 98372, United States
Spokane Washington, 99218, United States
Madison Wisconsin, 53792, United States
Linz , , Austria
Salzburg , , Austria
Wels , , Austria
Wien , , Austria
Essen , , Germany
Freiburg , , Germany
Gauting , , Germany
Grosshansdorf , , Germany
Göttingen , , Germany
Halle /Saale , , Germany
Hamburg , , Germany
Heidelberg , , Germany
Köln , , Germany
Mainz , , Germany
München , , Germany
Recklinghausen , , Germany
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