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 - SELECT-1

Study identifier:D1532C00079

ClinicalTrials.gov identifier:NCT01933932

EudraCT identifier:2013-001676-38

CTIS identifier:N/A

Recruitment Complete

Official Title

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)

Medical condition

Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV

Phase

Phase 3

Healthy volunteers

No

Study drug

Selumetinib, Docetaxel, Placebo, Pegylated G-CSF

Sex

All

Actual Enrollment

510

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 25 Sept 2013
Primary Completion Date: 07 Jun 2016
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria