Main trials published with targeted therapies in nonsmall cell lung cancer with ALK rearrangement
| First author [ref.] | Year | Phase | Treatment setting | Previous ALK inhibitor | ALK TKI | Comparison therapy | ORR# % | PFS# months |
| Solomon [40] | 2014 | III | First-line | No | Crizotinib (n=172) | Platinum doublet (n=171) | 74/45 | 10.9/7.0 (HR 0.45) |
| Soria [47] (ASCEND-4) | 2017 | III | First-line | No | Ceritinib (n=189) | Platinum doublet (n=187) | 73/27 | 16.6/8.1 (HR 0.55) |
| Hida [48] (J-ALEX) | 2017 | III | Previous chemotherapy allowed | No | Alectinib (n=103) | Crizotinib (n=104) | 92/79 | Not reached/10.2 (HR 0.34) |
| Peters [49] (ALEX) | 2017 | III | First-line | No | Alectinib (n=152) | Crizotinib (n=151) | 83/76 | Not reached/11.1 (HR 0.47) |
| Shaw [39] | 2013 | III | Second-line | No | Crizotinib (n=173) | Pemetrexed (n=174) | 65/20 | 7.7/3.0 (HR 0.49) |
| Shaw [42] | 2014 | I | Any lines | Accepted | Ceritinib ≥400 mg (n=114) | 58 | 7.0 | |
| Any lines | Crizotinib | Ceritinib (n=80) | 56 | 6.9 | ||||
| Shaw [43] | 2016 | II | Any lines | Crizotinib | Alectinib (n=69) | 48 | 8.1 | |
| Gettinger [45] | 2016 | I/II | Any lines | Accepted | Brigatinib (n=52) | 77 | ||
| Any lines | No | Brigatinib (n=4) | 100 | Not reached | ||||
| Any lines | Crizotinib | Brigatinib (n=52) | 74 | 14.5 | ||||
| Any lines | Accepted but brain metastasis | Brigatinib (n=6) | 83 | No event |
ALK: anaplastic lymphoma kinase; TKI: tyrosine kinase inhibitor; ORR: objective response rate; PFS: progression-free survival; HR: hazard ratio. #: comparisons presented as ALK TKI/comparison therapy.