Molecularly targeted therapies for advanced or metastatic non-small-cell lung carcinoma

Table 3 Major ongoing clinical trials with crizotinib for advanced non-small cell lung cancer¹

Trial number	Phase	Study design	Key entry criteria	PE
PROFILE 1007 (NCT00932893)	III	Crizotinib vs Pem or Doc as second-line	ALK(+) and 1 prior platinum-based chemo	PFS
PROFILE 1014 (NCT01154140)	III	Crizotinib + Pem + Cis/Carbo vs Pem + Cis/Carbo as first-line	ALK(+) and chemotherapy-naive	PFS
PROFILE 1005 (NCT00932451)	II	Crizotinib vs placebo as third-line	ALK(+) and PD in arm B of study PROFILE 1007	RR
PROFILE 1001 (NCT00965731)	I/II	Crizotinib + erlotinib vs erlotinib as second or third-line	Adenocarcinoma NSCLC and 1-2 prior chemo	MTD
PROFILE 1001 (NCT01121575)	I	Crizotinib + PF0299804	Acquired resistance to erlotinib or gefitinib	MTD

¹Data available at URL: http://www.cancer.gov/clinicaltrials. chemo: Chemotherapy; Pem: Pemetrexed; Doc: Docetaxel; Cis: Cisplatin; Carbo: Carboplatin; PD: Progressive disease; NSCLC: Non-small cell lung cancer; ALK: Anaplastic lymphoma kinase; PFS: Progression-free survival; RR: Response rate; MTD: Maximum tolerated dose; PE: Primary endpoint.