Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Histologically confirmed locally advanced or metastatic stage IIIB or IV NSCLC

Have experienced Complete Response (CR), Partial Response (PR) or Stable Disease (SD) following completion of 4 cycles of first-line platinum-based chemotherapy and are not progressing at time of entry into study (prior completed first-line combination bevacizumab therapy is permitted; however, current use of maintenance bevacizumab is not permitted. A maximum interval of 28 days between the last day of the treatment cycle and randomization

Patient has recovered from prior chemotherapy-related toxicity to ≤ grade 2

EGFR mutation status must be confirmed for participation in the study. EGFR analysis can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by APGD prior to randomization. If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization. Additionally, subjects should provide tissue blocks centrally for biomarker analysis whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient to provide four 4-micron, and five 10-micron sections)

Measurable disease (for those patients with PR or SD after first-line platinum-based chemotherapy) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)

Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 0 - 1

Previous adjuvant or neo-adjuvant treatment is permitted

Must be able to take oral medication

Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization

Adequate hematopoietic, hepatic, and renal function defined as follows:

* Neutrophil count ≥ 1.5 x 109/L

* Platelet count ≥ 100 x 109/L

* Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN)

* AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if patient has documented liver metastases

* Serum creatinine ≤ 1.5 x ULN

Potassium, magnesium and calcium within normal limits (supplementation and retesting is permitted)

Female patient must be either:

Of non child bearing potential:

* post-menopausal (defined as at least 1 year without any menses) prior to

Screening, or

documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)

* Or, if of childbearing potential:

must have a negative urine pregnancy test at Screening, and

must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 30 days after final study drug administration

* Female patient must not be breastfeeding at Screening or during the study period and for 30 days after final study drug administration

* Female patient must not donate ova starting at Screening and throughout the study period and for 30 days after final study drug administration

* Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 30 days after final study drug administration

* Male patient must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration

* Prior radiation therapy is permitted provided patients have recovered from acute toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have elapsed between the end of radiotherapy and randomization

* Prior surgery is permitted provided that the surgery was performed 21 days prior to randomization and adequate wound healing has occurred prior to randomization

* Patients must provide written (signed) informed consent to participate in the study and for use of tumor tissues

What this study is about