Table 1 Key Patient Selection Criteria

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