Study identifier:D419AC00001
ClinicalTrials.gov identifier:NCT02453282
EudraCT identifier:2015-001279-39
CTIS identifier:N/A
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).
Non-Small-Cell Lung Carcinoma NSCLC
Phase 3
No
Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin, Pemetrexed + Cisplatin, Pemetrexed + Carboplatin
All
1118
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC
Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.
Location
Location
Valencia, Spain, 46026
Location
Sevilla, Spain, 41009
Location
Heidelberg, Germany, 69126
Location
Hamburg, Germany, 20251
Location
Immenhausen, Germany, 34376
Location
Bad Berka, Germany, 99437
Location
Hemer, Germany, 58675
Location
Würzburg, Germany, 97080
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 |
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