Table 1.
Ongoing clinical trials, including ALK-i in combination with angiogenesis inhibitors, ICIs, chemotherapy or MEK inhibitors and novel oral ALK-i.
| Clinical Trials with Angiogenesis Inhibitors and ALK-i | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status |
Primary
Objective |
| NCT04227028 [95] | Brigatinib + Bevacizumab | I | Single group assignment, open label | Multicenter, 4 sites | 31 | Recruiting | Recommended dose, safety |
| NCT02521051 [96] | Alectinib + Bevacizumab | I/II | Single group assignment, open label | Multicenter, 2 sites | 43 | Recruiting | Recommended dose, safety |
| Clinical Trials with ICIs and ALK-i | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status | Primary Objective |
| NCT02013219 [97] | Atezolizumab + Erlotinib or Alectinib | I | Non-randomized, sequential assignment, open label | Multicenter, 17 sites | 52 | Completed | Safety, recommended dose, pharmacokinetics |
| NCT02393625 [98] | Nivolumab + Ceritinib | I | Non-randomized, parallel assignment, open label |
Multicenter, 11 sites | 57 | Active, not recruiting | MTD and/or recommended dose for expansion, overall response rate |
| NCT02584634 [99] | Avelumab + Erlotinib or Lorlatinib | I/II | Non-randomized, open label |
Multicenter, 21 sites | 43 | Active, not recruiting | DLTs, ORR, CR |
| Clinical Trials with Chemotherapy and ALK-i | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status | Primary Objective |
| NCT05200481 [100] | Carboplatin + Pemetrexed + Brigatinib | II | Randomized, open label, non-comparative |
Multicenter, 30 sites | 110 | Recruiting | PFS, OS, ORR |
| NCT04837716 [101] | Carboplatin + Pemetrexed + Bevacizumab + Ensartinib | I | Single group assignment, open label | Single center |
12 | Recruiting | Safety, recommended dose |
| Clinical Trials with MEK Inhibitors and ALK-i | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status | Primary Objective |
| NCT03202940 [102] | Alectinib + Cobimetinib | I/II | Single group assignment, open label | Single center |
31 | Recruiting | MTD |
| NCT04005144 [103] | Brigatinib + Binimetinib | I | Single group assignment, open label | Single center |
18 | Recruiting | Safety, tolerability |
| Clinical Trials with ALK-i Combination | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status | Primary Objective |
| NCT04292119 [104] | Lorlatinib + Crizotinib or Binimetinib, or TNO155 | Ib/II | Non-randomized, parallel assignment, open label | Multicenter, 2 sites | 96 | Recruiting | MTD, ORR |
| Clinical Trials with Novel Oral ALK-i | |||||||
| Trial Name | Intervention | Phase | Design | Center | Planned Participant Enrollment | Status | Primary Objective |
| NCT04849273 [105] | TPX-0131 | I/II | Single group assignment, open label | Multicenter, 15 sites | 210 | Recruiting | Safety, recommended dose, overall response rate |
| NCT05384626 [106] | NVL-655 | I/II | Non-randomized, open label, sequential assignment | Multicenter, 6 sites | 214 | Recruiting | DLTs, RP2D, ORR |
Abbreviations: ALK-i, ALK inhibitors; CR, complete response; DLTs, dose-limiting toxicities; ICIs, immune checkpoint inhibitors; MTD, maximum tolerated dose; ORR, objective response rate; OS, overall survival; PFS, progression free survival; RP2D, recommended phase 2 dose.