Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT01933932

This Phase III, double-blind, randomized study evaluates selumetinib with docetaxel versus placebo with docetaxel in KRAS mutation-positive NSCLC patients. Eligible participants are adults with advanced NSCLC who failed first-line therapy. Interventions include selumetinib or placebo capsules twice daily, docetaxel IV every 21 days, and pegylated G-CSF post-docetaxel.

Patient Parameters

Program Overview

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

Description

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Eligibility Criteria

Inclusion Criteria

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Male or female, aged 18 years or older
  • 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

Exclusion Criteria

  • Mixed small cell and non-small cell lung cancer histology.
  • 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.
  • Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  • Other concomitant anti-cancer therapy agents excepts steroids
  • Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  • Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Locations

FACILITYZIPCITYSTATE
Research Site80045AuroraColorado
Research Site33028Pembroke PinesFlorida
Research Site30318AtlantaGeorgia
Research Site60637ChicagoIllinois
Research Site70006MetairieLouisiana
Research Site02114BostonMassachusetts
Research Site02215BostonMassachusetts
Research Site01923DanversMassachusetts
Research Site10011New YorkNew York
Research Site10032New YorkNew York

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