TABLE 1

Main clinical trials with anaplastic lymphoma kinase inhibitors (ALKi) in lung cancer patients

Study name [ref.]	Phase	Patients n	Comparison drug	Experimental drug	Treatment setting	Efficacy outcome
PROFILE 1007 [40]	III	347	Pemetrexed or docetaxel	Crizotinib	After chemotherapy	Positive PFS 7.7 versus 3 months; response rate 65% versus 20%
PROFILE 1014 [41]	III	343	Cisplatin/carboplatin+pemetrexed	Crizotinib	First-line	Positive PFS 10.9 versus 7 months; response rate 74% versus 45%
NCT01283516 [42]	I	246		Ceritinib	After chemotherapy or ALKi	Post-crizotinib PFS 6.9 months, crizotinib-naïve PFS ≥18.4 months^#, all patients PFS 8.2 months; response rates 55%, 66% and 59%, respectively
JapicCTI-101264 [43]	I/II	46		Alectinib	After chemotherapy or ALKi	Response rate 87%

PFS: progression-free survival. ^#: median PFS not reached at the time of analysis.