A study of IRESSA treatment beyond progression in addition to Chemotherapy versus Chemotherapy alone - IMPRESS

Study identifier:D791LC00001

ClinicalTrials.gov identifier:NCT01544179

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Gefitinib, Placebo, Pemetrexed, Cisplatin

Sex

All

Actual Enrollment

265

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 15 Mar 2012
Primary Completion Date: 05 May 2014
Study Completion Date: 20 Nov 2019

Study design

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

Verification:

Verified 01 Dec 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria