TABLE I.
Targeted Therapies in Oncogene Driver-Specific Cohorts*
| TRIAL / NCT NUMBER | MOLECULAR COHORT | PHASE | THERAPY | PRIMARY OUTCOME | ESTIMATED COMPLETION DATE* |
|---|---|---|---|---|---|
| NCT01685138 | ALK+ NSCLC; crizotnib naïve | II | LDK 378 | OS | August 2014 |
| NCT01685060 | ALK+ NSCLC; crizotinib resistant | II | LDK 378 | ORR | September 2015 |
| NCT01828112 | ALK+ NSCLC; crizotnib restistant | III | LDK378 vs. Pemetrexed (500mg/m2) or docetaxel (75mg/m2) | PFS | July 2017 |
| NCT01871805 | ALK+ NSCLC; crizotinib resistant | I/II | Alectinib (RO5424802/CH542802) | Safety/ORR | July 2015 |
| NCT01449461 | ALK+, EGFR+, or ROS1+ NSCLC, other ALK+ tumors | I/II | AP26113 | RP2D/ORR | September 2015 |
| NCT01712217 | ALK+ or ROS1+ NSCLC, crizotinib resistant | I/II | AT13387 + crizotinib (phase I) | MTD/ORR | November 2014 |
| AT13387 plus crizotinib vs. AT13387 (phase II) | |||||
| NCT01945021 | ROS1+ NSCLC, East Asian ethnicity | II | Crizotinib | ORR | July 2016 |
| NCT01859026 | KRAS + NSCLC | I/IB | MEK162 + erlotinib | MTD | May 2016 |
| NCT01229150 | KRAS+ NSCLC | II | Selumetinib + erlotinib vs. selumetinib | PFS | September 2014 |
| NCT01395758 | KRAS+ NSCLC | II | Tivantinib (ARQ 197) + erlotinib vs. chemotherapy | PFS | December 2014 |
| NCT01427946 | KRAS+ NSCLC | Ib/II | Retaspimycin HCl (IPI-504) + everolimus | ORR | August 2015 |
| NCT01750281 | KRAS+ NSCLC | II | Selumetinib + docetaxel (75mg/m2) vs. selumetinib + docetaxel (60mg/m2) vs. placebo + docetaxel (75mg/m2) | PFS | July 2014 |
| NCT01933932 | KRAS+ NSCLC | III | Selumetinib + docetaxel (75mg/m2) vs. placebo + docetaxel (75mg/m2) | PFS | July 2016 |
| NCT01827267 | HER2+ NSCLC | II | Neratinib vs. neratinib +temsirolimus | ORR | April 2016 |
| NCT01336634 | BRAF+ NSCLC (V600E only) | II | Dabrafenib (GSK2118436) | ORR | September 2019 |
| NCT01514864 | BRAF+ or DDR2 + NSCLC | II | Dasatinib | ORR | July 2017 |
| NCT01306045 | BRAF+, PI3K+, KRAS+, HER2+ | II | Selumetinib (BRAF, KRAS), MK-2206 (PI3K), lapatinib (HER2) | ORR | Janurary 2017 |
| NCT01639508 | RET+ NSCLC | II | Cabozantinib | ORR | July 2015 |
| NCT01823068 | RET+ NSCLC | II | Vandetinib | ORR | September 2016 |
| NCT01813734 | RET+ NSCLC | II | Ponatinib | ORR | June 2015 |
| NCT01877083 | RET+ NSCLC | II | Levatinib | ORR | November 2014 |
| NCT01456325 | MET+ NSCLC | III | Onartuzumab + erlotinib vs. erlotinib + placebo | OS | June 2015 |
| NCT01900652 | MET+ NSCLC (previous EGFR therapy) | II | LY285358+ erlotinib vs. LY285358 | ORR | November 2014 |
| NCT01861197 | FGFR1+ NSCLC | II | Divotinib | ORR | Janurary 2015 |
*
Trial status accessed November 13,2013. (http://www.clinicaltrials.gov)
NSCLC: Non small cell lung cancer; OS: Overall survial; PFS: Progression free survival; ORR; Objective response rate; MTD: Maximum tolerated dose; RP2D: Recommended phase II dose
ALK: Anaplastic Lymphoma Kinase; KRAS: Kirsten ras oncogene homolog; HER2: Human epithelial receptor 2; RET: Rearranged in Transfection; PI3K: phosphatidylinositol 3-kinase; FGFR1: Fibroblast growth factor receptor 1