AZD9291 in Combination with Ascending Doses of Novel Therapeutics

Study identifier:D5160C00006

ClinicalTrials.gov identifier:NCT02143466

EudraCT identifier:2016-004752-29

CTIS identifier:N/A

Recruitment Complete

Official Title

A Multi-arm, Phase Ib, Open-Label, Multicentre Study to Assess the Safety,Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination with Ascending Doses of Novel Therapeutics in Patients with EGFRm+ Advanced NSCLC who have progressed following therapy with an EGFR TKI (TATTON).

Medical condition

Advanced Non Small Cell Lung Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

Part A - AZD9291 in combination with AZD6094, Part A - AZD9291 in combination with continuous selumetinib (Asian subjects), Part A - AZD9291 in combination with continuous selumetinib (non-Asian subjects), Part A - AZD9291 in combination with intermittent selumetinib, Part A - AZD9291 in combination with MEDI4736, Part B - AZD9291 in combination with AZD6094, Part B - AZD9291 in combination with selumetinib, Part B - AZD9291 in combination with MEDI4736, Part C - AZD6094 monotherapy (Japan only), Part C - AZD9291 in combination with AZD6094 (Japan only), Part D - AZD9291 in combination with AZD6094

Sex

All

Actual Enrollment

344

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 05 Aug 2014
Primary Completion Date: 04 Mar 2020
Estimated Study Completion Date: 31 Dec 2024

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria