Study of AZD9291 plus MEDI4736 versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours - CAURAL

Study identifier:D5165C00001

ClinicalTrials.gov identifier:NCT02454933

EudraCT identifier:2015-001858-15

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy (CAURAL)

Medical condition

Locally Advanced or Metastatic EGFR T790M+ NSCLC

Phase

Phase 3

Healthy volunteers

No

Study drug

AZD9291, MEDI4736

Sex

All

Actual Enrollment

29

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 15 Jul 2015
Primary Completion Date: 21 Aug 2017
Study Completion Date: 21 Jun 2023

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria