Table 2.
Active clinical trials of therapies targeting KRAS mutant lung cancer
| Study | Treatment | Design | Primary Endpoint | Rationale and Strategy |
|---|---|---|---|---|
| SELECT-1 study; (NCT01933932) | Selumetinib + Docetaxel | Randomized phase III | PFS | Improved efficacy of the combination over docetaxel alone |
| Phase II Study of VS-6063 (NCT01951690) | VS-6063 (Defactinib) | Phase II | PFS | Demonstrate if VS-6063 improves PFS within each cohort |
| AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, (NCT00890825) | AZD6244 + Docetaxel | Randomized, Phase II | OS | Compare the efficacy of the combination over docetaxel alone |
| Phase II Study of AZD6244 MEK-Inhibitor With Erlotinib (NCT01229150) | AZD6244 + Erlotinib | Randomized, Phase II | PFS | Compare the efficacy of combination over erlotinib alone |
| Erlotinib Plus Tivantinib (ARQ197) Versus Single Agent Chemotherapy (NCT01395758) | RQ 197 + erlotinib Vs. Pemetrexed, Docetaxel or Gemcitabine | Randomized, Phase II | PFS | Compare efficacy of combination erlotinib plus tivantinib over single agent chemotherapy. |
| Phase I/IB Trial of MEK162 in Combination With Erlotinib (NCT01859026) | MEK162 + Erlotinib | Non-Randomized, Phase I/IB | Maximum Tolerated Dose (MTD) | Safety of the combination MEK162 and erlotinib |
| Phase I/II Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the MEK Inhibitor PD-0325901 (NCT02022982) | Palbociclib + PD-0325901 | Phase I/II | Safety and Maximum Tolerated Dose (MTD) | Evaluate safety and compare efficacy of palbociclib in combination with another experimental drug PD-0325901 |
| Phase 1 Study of Trametinib in Combination With Chemoradiation (NCT01912625) | Trametinib + Chemoradiation | Phase I | DLT | Evaluate safety of trametinib in combination with chemotherapy and radiation therapy |
| JUNIPER (NCT02152631) | Abemaciclib + Best Supportive Care Vs. Erlotinib Plus Best Supportive | Randomized Phase III | PFS OS |
Compare efficacy of abemaciclib over erlotinib |