Table 1.

Key Patient Selection Criteria

Induction Phase
Inclusion Criteria	Exclusion Criteria
• Histologic or cytologic diagnosis of advanced, nonsquamous NSCLC • Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV disease prior to induction therapy not amenable to curative therapy • Prior radiation therapy to <25% of the bone marrow (not including whole pelvis radiation) if completed and patient has recovered 30 days before enrollment • ≥1 unidimensionally measurable lesion as defined by RECIST • Males and females ≥18 years of age • Performance status of 0 or 1 on the ECOG scale • Estimated life expectancy of ≥12 weeks • Adequate organ function (bone marrow reserve, renal, hepatic) • Use of an approved contraceptive method by male and female patients with reproductive potential • Negative serum or urine pregnancy test within 7 days before study enrollment for women with childbearing potential • Ability to comply with study and/or follow-up procedures • Signed informed consent document	• Squamous cell and/or mixed small cell, non-small cell histology • Prior systemic chemotherapy for lung cancer, including adjuvant therapy, for any stage of NSCLC • Concurrent administration of any other antitumor therapy • Treatment within last 30 days with a drug that has not received regulatory approval • Prior participation in a study investigating pemetrexed • Serious concomitant systemic disorder that would compromise ability to adhere to the protocol • Serious cardiac condition, such as myocardial infarction, angina, or heart disease • Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless malignancy diagnosed and treated ≥5 years previously without recurrence • Central nervous system metastases unless the patient has completed successful local therapy and has been off corticosteroids for ≥4 weeks • Clinically significant third space fluid collection that cannot be controlled by drainage or other procedure • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, other than an aspirin dose ≤1.3 g per day, for a 5-day period • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or corticosteroids
Maintenance Phase
Inclusion criteria
• ECOG PS of 0 or 1 • Documented radiographic evidence of a complete or partial tumor response or stable disease* • Completion of four cycles of induction chemotherapy

RECIST = Response Evaluation Criteria in Solid Tumors; ECOG PS = Eastern Cooperative Oncology Group performance status.

*Tumor assessment must occur between cycle 4 (day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized.