CRC 13107: Double-Blind, Randomized, Placebo-Controlled Study of Selumetinib in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (SELECT-1)
Purpose: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel.
Cancer () - Lung
Howard (Jack) West, M.D.
Swedish Cancer Institute
- Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
- KRAS mutation positive tumour sample as determined by the designated testing laboratory
- Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
- No xixed small cell and non-small cell lung cancer histology.
- Must not received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
- Must not be receiving or have received systemic anti-cancer therapy within 4 weeks prior to starting study treatment (6 weeks for nitrosoureas, mitomycin, and suramin) or any anti-cancer therapy which has not been cleared from the body by the time of starting study treatment.
- No prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).