Clinical trial NCT00111839 (phase 2, status: completed)
Conditions: lung cancer, non small cell lung carcinoma
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, D02.20, D02.21, D02.22
Drugs: pemetrexed, matuzumab
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
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