Phase III open label First Line Therapy study of MEDI 4736 (Durvalumab) with or without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC) - MYSTIC

Study identifier:D419AC00001

ClinicalTrials.gov identifier:NCT02453282

EudraCT identifier:2015-001279-39

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).

Medical condition

Non-Small-Cell Lung Carcinoma NSCLC

Phase

Phase 3

Healthy volunteers

No

Study drug

Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin, Pemetrexed + Cisplatin, Pemetrexed + Carboplatin

Sex

All

Actual Enrollment

1118

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 21 Jul 2015
Primary Completion Date: 04 Oct 2018
Estimated Study Completion Date: 31 Dec 2024

Study design

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

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria