Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Historically confirmed advanced NSCLC stages IIIB or IV

Exon 19 deletion or exon 21 activating mutation in EGFR

EGFR mutation status must be confirmed for participation in the study. EGFR 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 sponsor 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 for biomarker central 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 according to RECIST (version 1.1)

ECOG performance status 0-1

Must be able to take oral medication

Fasting glucose \<= 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic anti hyperglycemic therapy is permitted if the dose has been stable for \>= 4 weeks at the time of randomization

Adequate hematopoietic, hepatic, and renal function as follows:

* Neutrophil count \>= 1500/uL

* Platelet count \>= 100,000/uL

* Serum creatinine \<= 1.5 x Upper Limit of Normal (ULN)

* Potassium, magnesium, and calcium within normal limits (supplementation and re-testing is permitted)

* Total bilirubin \<= 1.5 x ULN

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

Female subject must be either:

* Of non child bearing potential:

1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or

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

* Or, if of childbearing potential:

1. must have a negative urine pregnancy test at Screening, and

2. must use two forms of birth control (at least 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. Acceptable forms include:

1. Established use of oral, injected or implanted hormonal methods of contraception;

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);

3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

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

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

Male subject 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. Acceptable forms include:

1. Established use of oral, injected or implanted hormonal methods of contraception.

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

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

Patients must provide written informed consent to participate in the study

Patients may not have received chemotherapy for advanced NSCLC. Previous adjuvant and/or neoadjuvant treatment for NSCLC is permitted

Prior radiation therapy is permitted provided patients have recovered from the 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 done \>= 28 days prior to randomization and adequate wound healing has occurred prior to randomization

What this study is about