Status:
COMPLETED
Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer
Lead Sponsor:
EMD Serono
Conditions:
Lung Cancer
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00111839
Start Date
May 31 2005
End Date
March 31 2009
Last Update
April 6 2018
Active Locations (58)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
2
University of Arkansas, Arkansas Cancer Research Center
Little Rock, Arkansas, United States, 72205
3
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
4
Sharp Memorial Hospital
San Diego, California, United States, 92123