Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer
Condition: Lung Cancer; Non Small Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Matuzumab
Intervention description: Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.; Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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