Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Newly diagnosed NSCLC in stage IIIB (with a cytologically positive pleural or pericardial effusion) or stage IV, according to the sixth edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual37;
Age > 18 years;
No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC;
Histological confirmation of any non-squamous histological type of NSCLC, given the recent findings of treatment benefit in this population44;
ECOG performance status of 2;
At least 3 weeks must have elapsed since major surgery, and at least 1 week since mediastinoscopy, pleuroscopy, or thoracostomy;
Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (computed tomography [CT] or magnetic resonance imaging [MRI] scan) or as ≥ 10 mm with spiral CT scan;

Adequate organ function as indicated by the following:

White blood cell (WBC) count ≥ 3500/mm3
Absolute neutrophil count (ANC) ≥1500/mm3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/ mm3
Total bilirubin ≤ 2 times the upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the ULN, unless liver metastases present, in which case AST and ALT have to be ≤ 5 times the ULN
Estimated glomerular filtration rate (GFR) ≥ 45 mL/min
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration;
Fertile patients (male or female) must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months thereafter;
Patients must sign an Informed Consent Form;
Have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol requirements;

Exclusion Criteria:

ECOG performance status other than 2;
Prior chemotherapy for the treatment of NSCLC;
Lesions that have been irradiated cannot be included as sites of measurable disease. If the only measurable lesion was previously irradiated the patient cannot be included;
Symptomatic central nervous system (CNS) metastases. Prior CNS metastases are allowed if the patient is neurologically stable and not receiving corticosteroids;
Serious uncontrolled intercurrent medical or psychiatric illness;
Active and ongoing systemic infection;
Second primary malignancy (except in situ carcinoma of the cervix, in situ carcinoma of the bladder, adequately treated basal-cell carcinoma of the skin, adequately treated squamous-cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment and without recurrence);
Known hypersensitivity to pemetrexed;
known hypersensitivity to carboplatin;
Pregnancy or lactation;
Use of any investigational agent within 30 days prior to enrollment into the study;
Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDSs) agents for 2 days before, the day of and 2 days after the dose of pemetrexed, in the case of NSAIDs with short half-life, such as ibuprofen (total of 5 days), in patients with a GFR between 45 and 79 mL/min; and for 5 days before, the day of and 2 days after the dose of pemetrexed, in the case of NSAIDs with long half-life (total of 8 days, see 7.4.2) in all patients; patients with a GFR ≥ 80 mL/min may receive concomitant study treatment and ibuprofen or aspirin (≤ 1.3 g/day);
Inability to comply with requirements and procedures of study.