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. 2012 Jun;19(Suppl 1):S73–S85. doi: 10.3747/co.19.1132

TABLE I.

Current or planned trials involving targeted agents relevant to patients with non-small-cell lung cancer

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Targeted agent ClinicalTrials.gov ID Phase Status Population Estimated enrollment (n) Estimated completion date Trial site
egfr inhibition
  Erlotinib vs. docetaxel NCT00637910 iii Recruiting Stage iiib/iv nsclc, wild-type EGFR, prior platinum chemotherapy, no prior taxanes 850 Feb 2013 Italy
  Erlotinib + cetuximab NCT00397384 i/ii Active, not recruiting Advanced malignancy: head-and-neck, gastrointestinal tract, nsclc, colorectal 49 Jan 2013 U.S.A.
  Erlotinib + pazopanib NCT01027598 ii Active, not recruiting Stage iiib/iv nsclc, 1 prior chemotherapy 90 Dec 2011 U.S.A.
  Erlotinib + BKM120 NCT01487265 i/ii Not yet recruiting Progressive nsclc, prior chemotherapy, sensitivity to egfr-tkis 73 Oct 2014 U.S.A.
  Erlotinib + OSI-906 NCT01221077 ii Recruiting Stage iiib/iv nsclc, EGFR mutation, chemotherapy-naïve 86 Jul 2014 Int
  Erlotinib + ARQ 197 (tivantinib) NCT01377376 iii Recruiting Stage iiib/iv nsclc, wild-type EGFR, prior platinum chemotherapy — Dec 2013 Japan
  Erlotinib + ARQ 197 (tivantinib) NCT01244191 iii Recruiting Stage iiib/iv nsclc, 2 prior lines of chemotherapy 988 Jul 2 013 Int
  Erlotinib + dovitinib NCT01515969 i Not yet recruiting Stage iiib/iv nsclc, prior treatment 30 Dec 2013 U.S.A.
  Erlotinib + hydroxychloroquine NCT00977470 ii Recruiting Stage iv nsclc, EGFR positive, no prior treatment 76 Aug 2013 U.S.A.
  Carboplatin, paclitaxel, bevacizumab ± erlotinib NCT00976677 ii Active, not recruiting Stage iii/iv nsclc, non-squamous, nonsmokers 189 Jul 2012 U.S.A.
  Gefitinib NCT01203917 iv Recruiting Stage iiib/iv nsclc, Caucasian, EGFR mutation 100 Aug 2012 Eur
  Gefitinib (maintenance) NCT01404260 iii Active, not recruiting Stage iiib/iv ncslc, stable disease after chemotherapy, EGFR unknown, never or light smokers 218 Apr 2014 China
  Gefitinib (rechallenge) NCT01530334 ii Not yet recruiting Previous response to gefitinib, subsequent chemotherapy 92 Sep 2013 Italy
  Gefitinib vs. pemetrexed NCT00891579 ii Recruiting Stage iiib/iv nsclc, wild-type EGFR, prior platinum chemotherapy 150 May 2012 China
  AP26113 NCT01449461 i/ii Recruiting Advanced/metastatic malignancy 130 Sep 2015 U.S.A.
  CO-1686 NCT01526928 i/ii Not yet recruiting Stage iiib/iv nsclc, EGFR mutation 70 May 2014 U.S.A.
  Afatinib NCT00525148 ii Active, not recruiting Stage iiib/iv nsclc, EGFR mutation 120 Jul 2012 Int
  Afatinib NCT00711594 ii Active, not recruiting Stage iiib/iv nsclc, prior platinum chemotherapy, progressed after gefitinib or erlotinib 72 Dec 2012 Japan
  Afatinib NCT01542437 ii Recruiting Stage iiib/iv nsclc, at least 1 prior chemotherapy 150 Dec 2012 Mexico
  Afatinib + pemetrexed NCT01169675 i Recruiting Advanced solid tumours 90 May 2012 Canada
  PF-00299804 NCT01000025 iii Recruiting Stage iiib/iv nsclc 720 Nov 2012 Int
  MM121 + erlotinib NCT00994123 i/ii Recruiting Stage iiib/iv nsclc 260 Feb 2013 U.S.A.
  MM121 + irinotecan + cetuximab NCT01451632 i Recruiting Advanced malignancy, no standard options remaining 45 Oct 2013 U.S.A.
  Afatinib + sirolimus NCT00993499 i Recruiting Stage iiib/iv nsclc, EGFR mutation or progression after erlotinib in EGFR wild-type 42 Aug 2014 Spain
braf inhibition
  AZD6244 NCT01306045 ii Recruiting Stage iv nsclc, sclc, and thymic cancer 600 Jan 2017 U.S.A.
  AZD6244 NCT00888134 i Active, not recruiting BRAF-mutated malignancy 66 Apr 2012 U.S.A.
  Dasatinib NCT01514864 ii Not yet recruiting Stage iv nsclc or melanoma, with DDR2 mutation or BRAF mutation 95 Mar 2017 Int
Akt inhibition
  MK-2206 + erlotinib NCT01294306 ii Recruiting Advanced nsclc, progressed after initial response to erlotinib 90 Nov 2011 U.S.A.
  MK-2206 + gefitinib NCT01147211 i Recruiting Advanced nsclc, prior egfr inhibitor, prior platinum chemotherapy 21 Dec 2012 Taiwan
pi3k inhibition
  BYL719 + MEK162 NCT01449058 i/ii Not yet recruiting Advanced incurable tumour 58 Mar 2014 Int
  XL147 + erlotinib NCT00692640 i Active, not recruiting Advanced incurable tumour 65 Nov 2011 U.S.A.
Mek1 inhibition
  GSK2118436 NCT01362296 ii Recruiting Stage iv nsclc, positive mutational status for KRAS, BRAF, NRAS, MEK1, 1 prior platinum treatment 141 Aug 2012 Int
  BKM120 + MEK162 NCT01363232 i/ii Recruiting Advanced incurable tumour 58 Jul 2012 Int
  BEZ235 +MEK162 NCT01337765 i/ii Recruiting Advanced incurable tumour 55 Jun 2013 Int
  GSK1120212 + gemcitabine NCT01324258 i Recruiting Advanced incurable tumour, Japanese patients 19 Jun 2012 Japan
  GSK1120212 + BKM120 NCT01155453 i Recruiting Advanced incurable tumour 60 Jul 2013 Int
hdac inhibition
  LBH589 + erlotinib NCT00738751 i Not yet recruiting Stage iv nsclc or stage iv head-and-neck cancer 44 Dec 2012 U.S.A.
  Vorinostat + hydroxychloroquine NCT01023737 i Recruiting Advanced incurable tumour 30 Nov 2012 U.S.A.
  Vorinostat + NPI-0052 NCT00667082 i Recruiting Advanced/metastatic nsclc, pancreatic cancer, melanoma, lymphoma 40 Sep 2009 Aus
  CUDC-101 NCT01171924 ib Active, not recruiting Stage iv nsclc with EGFR mutation (exons 19/21), progressed with erlotinib, breast, gastric, head-and-neck 40 Oct 2011 U.S.A.
  Vorinostat + sirolimus NCT01087554 i Recruiting Advanced incurable biopsy-proven solid tumour 65 Mar 2014 U.S.A.
  Vorinostat or sirolimus + hydroxychloroquine NCT01266057 i Recruiting Advanced or metastatic malignancy, failed treatment 160 Apr 2015 U.S.A.
  Vorinostat + gefitinib NCT01027676 ii/iii Recruiting Stage iiib/iv nsclc, 1 platinum-based chemotherapy 50 Dec 2012 Korea
  Vorinostat + bortezomib NCT00798720 ii Completed recruiting Advanced nsclc, 2 prior chemotherapy regimens 33 Dec 2011 U.S.A.
  Entinostat + sorafenib NCT01159301 i Recruiting Advanced incurable tumour 44 May 2011 U.S.A.
  PXD101 (belinostat) + bevacizumab + carboplatin + paclitaxel NCT01090830 i/ii Recruiting Stage iv nsclc, no previous treatment 28 Sep 2012 U.S.A.
  LBH589 + pemetrexed NCT00907179 i/ii Recruiting Stage iv nsclc, 1 prior chemotherapy regime 50 Jun 2013 U.S.A.
  Vorinostat + pazopanib NCT01339871 i Recruiting Advanced incurable tumour 134 Apr 2016 U.S.A.
Alkinhibition
  Crizotinib (PF-02341066) NCT01500824 ii Not yet recruiting Stage iv nsclc, non-squamous, East Asian, with ALK fusion gene, 1 prior chemotherapy 50 Feb 2014 China
  Crizotinib (PF-02341066) NCT00932451 ii Recruiting Stage iv nsclc, with ALK fusion gene 100 Mar 2013 Int
  Crizotinib (PF-02341066) + PF-00299804 (pan-her inhibitor) NCT01121575 i Recruiting Stage iv nsclc, acquired resistance to gefitinib and erlotinib 70 Nov 2012 Int
  Crizotinib (PF-02341066) + PF-00299804 (pan-her inhibitor) NCT01441128 i Recruiting Stage iv nsclc 22 Nov 2016 U.S.A.
  Crizotinib (PF-02341066) vs. pemetrexed or docetaxel NCT00932893 iii Recruiting Stage iv nsclc, with ALK fusion gene 318 Feb 2013 Int
  LDK378 NCT01283516 i Recruiting Stage iv nsclc, with ALK fusion gene 70 Jul 2013 Int
  AP26113 NCT01449461 i/ii Recruiting Stage iv nsclc 130 Sep 2015 U.S.A.
cmet inhibition
  PF-02341066 (cmet inhibitor) + PF-00299804 (pan-her inhibitor) NCT01121575 i Recruiting Advanced nsclc, resistance to erlotinib and gefitinib 70 Nov 2012 Int
KRAS mutations
  AZD6244 + erlotinib NCT01229150 ii Recruiting Advanced nsclc, 1 prior platinum chemotherapy 100 Sep 2014 U.S.A.
  Erlotinib + ARQ 197 vs. single-agent chemotherapy NCT01395758 ii Recruiting Stage iv nsclc, with KRAS mutation 98 Jun 2012 U.S.A.
  GSK1120212 vs. docetaxel NCT01362296 ii Recruiting Stage iv nsclc, positive mutational status for KRAS, NRAS, BRAF, MEK1 141 Aug 2012 Int

nsclc = non-small-cell lung cancer; egfr-tki = epidermal growth factor receptor tyrosine kinase inhibitor; Int = international (more than one continent); Eur = Europe; sclc = small-cell lung cancer; Aus = Australia; her = human epidermal growth factor receptor.