. Author manuscript; available in PMC: 2014 Apr 18.

Published in final edited form as: Expert Rev Anticancer Ther. 2013 Jun;13(6):745–758. doi: 10.1586/era.13.47

Table 3.

Studies of crizotinib in advanced ALK-positive non-small-cell lung cancer.

Study (year)	Phase	Study arm(s)	ORR and PFS	OS	Ref.
Initial dose–escalation/expansion study (2010); n = 143 ALK-positive NSCLC patients; 84% pretreated	I	Crizotinib 250 mg b.i.d. p.o. daily	ORR: 60.8% (95% CI: 52.3– 68.9); PFS: 9.7 months (95% CI: 7.7–12.8)	OS at 12 months: 74.8% (95% CI: 66.4–81)	[56]
PROFILE 1005(2012); n = 255; 85% pretreated	II	Single-arm crizotinib 250 mg b.i.d. p.o. daily	ORR: 53% (95% CI: 47–60); PFS: 8.5 months (95% CI: 6.2–9.9)	OS: not yet mature	[58]
PROFILE 1007(2013); n = 347; second line	III	Crizotinib vs docetaxel or pemetrexed	ORR: crizotinib 65.3% vs 19.3% chemotherapy; p < 0.0001 PFS: crizotinib 7.7 vs 3.0 months chemotherapy; p < 0.001	OS: not yet mature	[59]
PROFILE 1014; first-line advanced ALK-positive nonsquamous NSCLC (ClinicalTrials.gov identifier: NCT01154140)	III	Crizotinib vs cisplatin/pemetrexed or carboplatin/pemetrexed	Not available as yet	Not available as yet	[106]

b.i.d.: Two-times a day: NSCLC: Non-small-cell lung cancer: ORR: Overall response rate: OS: Overall survival: PFS: Progression-free survival: p.o.: Per orem.