Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer
Lung Cancer, Non Small Cell Lung Carcinoma

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer
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
Sites / Locations
- Arizona Clinical Research Center
- University of Arkansas, Arkansas Cancer Research Center
- University of Southern California/Norris Cancer Center
- Sharp Memorial Hospital
- Holy Cross Hospital
- Integrated Community Oncology Network
- Cancer Center or Florida
- Peachtree Hematology and Oncology
- Georgia Cancer Specialists
- Rush University Medical Center
- University of Illinois
- Cancer Care Specialists of Central Illinois
- Cancer Institute of Alexian Brothers
- Indiana Oncology Hematology Consultants
- Hematology-Oncology of Indiana PC
- Northern Indiana Cancer Research Consortium
- Kansas City Cancer Center
- Louisville Oncology
- James Graham Brown Cancer Center
- Hematology-Oncology Clinic
- Frederick Memorial Hospital
- Tuffs-New England Medical Center
- Henry Ford Health Systems
- West Michigan Regional Cancer and Blood Center
- University of Minnesota
- University of Missouri
- Deaconess Billings Clinic
- Nebraska Hematology-Oncology, PC
- Dartmouth Hitchcock Medical Center
- New York Oncology
- University of North Carolina
- Presbyterian Hospital Cancer Center
- The Cleveland Clinic Foundation
- Dayton Oncology and Hematology
- Providence Portland Medical Center
- Hematology & Oncology Associates of NEPA
- Thomas Jefferson University Hospital
- Mary Crowley Research Center
- Tyler Cancer Center
- Rainer Oncology Professional Services
- Cancer Care Northwest
- University of Wisconsin
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Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Pemetrexed Alone
Pemetrexed Plus Matuzumab 800 mg per Week
Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
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.
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.
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.