Wednesday, April 17, 2019 The IND215 trial has been permanently closed. IND215 is a Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens. Primary publication citation Goffin JR, Nicholas G, Mates M, Tu D, Chen E, Laurie SA, Juergens R, Robinson A, Goss G, Reaume M, S, Christink K, Maize C, MacFarlan S, X, Ritter H, Seymour L, Bradbury PA Canadian Cancer Trials Group (CCTG) IND215: A phase Ib study of Selumetinib in patients with untreated advanced or metastatic NSCLC who are receiving standard chemotherapy regimens Investigational New Drugs:ONLINE, 2018 Primary Objective To determine the recommended phase II dose (RP2D) and safety profile of selumetinib in patients with advanced/metastatic NSCLC in combination with: pemetrexed; pemetrexed and cisplatin; paclitaxel and carboplatin. Secondary Objectives: 1) to obtain pharmacokinetic (PK) profiles of selumetinib when given daily continuously in combination with chemotherapy; 2) to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material that may influence response; the use of plasma as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status; and serum exploratory markers that may predict response to selumetinib; 3) preliminary assessment of efficacy in all patients and in an expansion cohort of up to 10 patients with KRAS positive NSCLC. For more information please visit the IND215 Trial Page
