Pemetrexed Disodium and Carboplatin or Cisplatin With or Without Erlotinib Hydrochloride in Treating Patient With Stage IV Non-Small Cell Lung Cancer Resistant to First-Line Therapy With Erlotinib Hydrochloride or Gefitinib

Signed informed consent prior to initiation of any study-specific procedure or treatment. Informed Consent Form must be signed within 14 days of study treatment initiation.

Age \> 18 years

Able and willing to comply with the protocol

Histologically- or cytologically-confirmed Stage IV NSCLC with an EGFR exon-19 deletion or L858R mutation

Must have received at least 6 months of first-line therapy with erlotinib or gefitinib

Clinical evidence of progression on first-line EGFR TKI therapy

Adequate hematological function within 7 days of study treatment initiation:

1. Absolute neutrophil count (ANC) \> 1.5 x 109/L AND

2. Platelet count \> 100 x 109/L AND

3. Hemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level)

Adequate liver function within 7 days of study treatment initiation:

1. Total bilirubin \< 1.5 x upper limit of normal (ULN) AND

2. AST and ALT \< 2.5 x ULN in patients without liver metastases; \< 5 x ULN in patients with liver metastases

Adequate renal function within 7 days of study treatment initiation:

a. Serum creatinine \< 1.25 x ULN or calculated creatinine clearance \> 50 mL/min (Creatinine clearance may be calculated per institutional standards.)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of study treatment initiation

Patients with stable, treated brain metastases are eligible for study participation and may be on a stable dose of steroids at screening. Anticonvulsants (at stable dose) are allowed. Radiotherapy and stereotactic radiosurgery to the brain must be completed at least 28 days prior to randomization

Female patients must not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drugs. Female patients with an intact uterus (unless amenorrhoeic for the last 12 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.

Fertile male patients must agree to use effective contraception during the study and for a period of at least 3 months following the last administration of study drugs

What this study is about