Erlotinib（Tarceva®）聯合 OSI-906 用於帶有表皮生長因子受體（EGFR）基因活化突變的晚期非小細胞肺癌（NSCLC）患者的研究

納入條件

• 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:
• 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 (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:
• Established use of oral, injected or implanted hormonal methods of contraception;
• Placement of an intrauterine device (IUD) or intrauterine system (IUS);
• 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:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.