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) |
---|---|---|---|---|---|---|---|---|---|---|
Small-molecule EGFR TKIs | ||||||||||
 1st Generation EGFR TKI | ||||||||||
  Gefitinib (Iressa®/ZD1839) | ||||||||||
   Gefitinib (250 mg/d) | NCT00322452 | IPASS | NSCLC | Chemotherapy | 2006–2010 | AstraZeneca | III | 1329 | 18.6 vs 17.3 | 5.7 vs 5.8/24.9 vs 6.7% |
   Gefitinib (250 mg/d) | NCT01203917 | IFUM | NSCLC (EGFR+) | None | 2010–2013 | AstraZeneca | IV | 1060 | 19.2 | 7.0 |
  Erlotinib (Tarceva®) | ||||||||||
   Erlotinib (150 mg/d) | NCT00036647 | BR.21 | NSCLC | Placebo | 2001–2004 | OSI Pharmaceuticals | III | 731 | 6.7 vs 4.7 | 2.2 vs 1.8 |
   Erlotinib (150 mg/d) | NCT00556712 | SATURN | NSCLC | Placebo | 2010–2013 | Hoffmann-La Roche | Obs | 289 | 12.4 vs 11.0 | 12.3 vs 11.1 |
   Erlotinib (150 mg/d) | NCT01328951 | IUNO | NSCLC | Placebo | 2011–2016 | Hoffmann-La Roche | III | 643 | 9.7 vs 9.5 | 3.0 vs 2.8 |
   Erlotinib (100 mg/d) + Gemcitabine (1000 mg/m2/w) | NCT02694536 |  | Pancreatic cancer | None | 2006–2009 | Hoffmann-La Roche | III | 80 | 7.5 | 4.9 |
  Lapatinib (Tykerb®) | ||||||||||
   Lapatinib (1250 mg/d) + capecitabine (2000 mg/m2) | NCT00078572 |  | Breast (HER2+) | Capecitabine | 2004–2006 | GSK | III | 408 | 17.3 vs 14.9 | 7.2 vs 4.3 |
   Lapatinib (1500 mg/d) + letrozole (2.5 mg/d) | NCT00073528 |  | Breast (ER/PR +) | Letrozole | 2003–2018 | Norvatis | III | 1285 | 33.3 vs 32.3 | 8.1 vs 3.0 |
   Lapatinib (1500 mg/d) | NCT00374322 | TEACH | Breast (HER2+) | Placebo | 2006–2013 | GSK | III | 3166 | 7.3 vs 8.0% | 13.3 vs 15.8% |
 2nd Generation EGFR TKI | ||||||||||
  Afatinib (BIBW 2992/Gilotrif®) | ||||||||||
   Afatinib (50 mg/d) | NCT00525148 | LUX-Lung 2 | NSCLC | None | 2007–2015 | Boehringer Ingelheim | II | 129 | 26.8 | 10.2 |
   Afatinib (40 mg/d) | NCT00949650 | LUX-Lung 3 | NSCLC, Adenocarcinoma | Pemetrexed + cisplatin | 2009–2017 | Boehringer Ingelheim | III | 345 | 28.2 vs 28.2 | 11.2 vs 6.9 |
   Afatinib (40 mg/d) | NCT01121393 | LUX-Lung 6 | NSCLC, Adenocarcinoma | Gemcitabine + cisplatin | 2010–2017 | Boehringer Ingelheim | III | 364 | 23.1 vs 23.5 | 11.0 vs 5.6 |
   Afatinib (40-50 mg/d) | NCT01523587 | LUX-Lung 8 | NSCLC | Erlotinib | 2012–2017 | Boehringer Ingelheim | III | 795 | NR | 2.4 vs 1.9 |
   Afatinib (40 mg/d) + vinorelbine (25 mg/m2) | NCT01125566 | LUX-Breast 1 | Breast (HER2+) | Trastuzumab + vinorelbine | 2010–2018 | Boehringer Ingelheim | III | 508 | 19.6 vs 28.6 | 5.5 vs 5.6 |
   Afatinib (40 mg/d) | NCT01271725 | LUX-Breast 2 | Breast (HER2+) | Afatinib + vinorelbine + paclitaxel | 2011–2017 | Boehringer Ingelheim | II | 74 | NR | NR |
   Afatinib (40 mg/d) | NCT01441596 | LUX-Breast 3 | Breast (HER2+) | Investigator’s choice | 2011–2015 | Boehringer Ingelheim | II | 121 | 13.3 vs 12.0 | 2.7 vs 4.2 |
  Dacomitinib (Vizimpro®) | ||||||||||
   Dacomitinib (45 mg/d) | NCT01774721 | ARCHER 1050 | NSCLC (EGFR mutant) | Gefitinib | 2013–2016 | SFJ Pharmaceuticals | III | 440 | 16.9 vs 11.9 | 14.7 vs 9.2 |
Vandetanib (Caprelsa®) | ||||||||||
   Vandetanib (300 mg/d) | NCT00410761 | ZETA | Thyroid | Placebo | 2006–2019 | Sanofi | III | 437 | 13.9 vs 16.0% | 30.5 vs 19.2 |
   Vandetanib (300 mg/d) | NCT00409968 NCT00411671 NCT00411632 NCT00410059 NCT00410189 | BATTLE Program | NSCLC | Erlotinib, erlotinib + bexarotene, sorafenib | 2006–2018 | United States Department of Defense | II | 255 | 33.0% | 1.8 |
  Neratinib (Nerlynx®) | ||||||||||
   Neratinib (240 mg/d) | NCT00878709 | ExteNET | Breast Cancer | Placebo | 2009–2020 (active) | Puma Biotechnology, Inc. | III | 2840 | 4.7 vs 8.0 (DFS) | NR |
 3rd Generation EGFR TKI | ||||||||||
  Osimertinib (Tagrisso®) | ||||||||||
   Osimertinib (80 mg/d) | NCT01802632 | AURA extension | NSCLC (EGFR-T790 M) | None | 2013–2018 | AstraZeneca | I/II | 201 [603] | NR | 9.7 |
   Osimertinib (80 mg/d) | NCT02094261 | AURA 2 | NSCLC (EGFR-T790 M) | None | 2014–2019 | AstraZeneca | II | 210 | NR | 8.6 |
   Osimertinib (80 mg/d) | NCT02151981 | AURA 3 | NSCLC | Chemotherapy | 2014–2018 (active) | AstraZeneca | III | 419 | NR | 10.1 vs 4.4 |
  Rociletinib | ||||||||||
   Rociletinib (500–750 mg BD) | NCT01526928 |  | NSCLC | None | 2012–2019 | Clovis Oncology, Inc. | I/II | 605 |  | 13.1 |
  Naquotinib | ||||||||||
   Naquotinib (dose NR) | NCT02588261 | SOLAR | NSCLC | Erlotinib or gefitinib | 2016–2017 (terminated) | Astellas Pharma Inc | III | 530 | NR | NR |