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 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Monotherapy PD-L1 monoclonal Antibody monotherapy. | - |
| Experimental: Combination Therapy PD-L1+Tremelimumab combination therapy | - |
| Active Comparator: Standard of Care Standard of Care chemotherapy treatment | Drug: Paclitaxel + Carboplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + Cisplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + Carboplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + Cisplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + Carboplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy |
Contacts
Investigators
Principal Investigator
Stuart McIntosh
AstraZeneca, Alderley Park, Cheshire, UK
