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Table 5 Landmark clinical trials in the development of ALK inhibitors

From: Clinical development of targeted and immune based anti-cancer therapies

Drug Name Clinical Trial ID Trial Name Population Comparator Year Sponsor Phase N Median OS (months) Median PFS (months)
ALK inhibitors
 1st Generation ALK-inhibitors
  Crizotinib (Xalkori®)
  Crizotinib (50–2000 mg/d) NCT00585195 PROFILE 1001 Advanced cancer Rifampin, Itraconazole 2006–2023 Pfizer I 600 NR 9.7
  Crizotinib (250 mg BD) NCT00932451 PROFILE 1005 NSCLC None 2010–2015 Pfizer II 1069 21.8 8.1
  Crizotinib (250 mg BD) NCT0093283 PROFILE 1007 NSCLC Permetrexed or docetaxel NR Pfizer III 172 20.3 vs 22.8 7.7 vs 3.0
  Crizotinib (250 mg BD) NCT01154140 PROFILE 1014 Non-squamous lung cancer Platinum + permetrexed 2011–2013 Pfizer III 343 NR 10.9 vs 7.0
 Ceritinib (Zykadia®)
  Ceritinib (750 mg/d) NCT01283516 ASCEND-1 Tumors (ALK+) None 2011–2013 Novartis I 304 16.7 7.0
  Ceritinib (750 mg/d) NCT02336451 ASCEND-2 NSCLC None 2015–2018 Novartis II 160 NR 5.7
  Ceritinib (750 mg/d) NCT01685138 ASCEND-3 NSCLC None 2008–2018 Novartis II 125 NR 10.8
  Ceritinib (750 mg/d) NCT01828099 ASCEND-4 NSCLC Chemotherapy 2013–2016 Novartis III 375 NR 16.6 vs 8.1
  Ceritinib (750 mg/d) NCT01828112 ASCEND-5 NSCLC Chemotherapy 2013–2017 Novartis III 232 20.1 vs 18.1 5.4 vs 1.6
  Ceritinib (750 mg/d) NCT02299505 ASCEND-8 NSCLC None 2015–2016 Novartis I 318 NR NR
 Alectinib (Alcensa®)
  Alectinib (600 mg BD) NCT01871805 NP28761 NSCLC None 2013–2017 Hoffmann-La Roche I/II 134 27.9 8.2
  Alectinib (600 mg BD) NCT01801111 NP28673 NSCLC None 2013–2014 Hoffmann-La Roche I/II 138 12.1 7.5
  Alectinib (600 mg BD) NCT02075840 ALEX NSCLC Crizotinib 2014–2017 Hoffmann-La Roche III 303 NR 25.7 vs 10.4
 Brigatinib (Alunbrig™)
  Brigatinib (90 mg/d) NCT01449461   NSCLC None 2011–2015 Ariad I/II 137 NR 16.3
  Brigatinib (90 mg/d) NCT02094573   NSCLC None 2014–2016 Ariad II 222 46% 9.2
  Brigatinib (90 mg/d) NCT02737501 ALTA-L1 NSCLC Crizotinib 2016–2020 Ariad III 275 85 vs 86% 67 vs 43%
Lorlatinib
  Lorlatinib (10-200 mg/d) NCT01970865 CROWN NSCLC None 2014–2017 Pfizer II 367 22.3 5.3