Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

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