Studieoverzicht

Study name: 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).

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
NCT Id	NCT02453282
Host / recruiting site 1	Jeroen Bosch Ziekenhuis	Enrollment	Closed
Therapy line	First line (1L)
Design	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
Intervention	BIOLOGICAL: MEDI4736 (Durvalumab) BIOLOGICAL: MEDI4736 (Durvalumab)+Tremelimumab DRUG: Paclitaxel + Carboplatin Chemotherapy Agents DRUG: Gemcitabine + Cisplatin Chemotherapy Agents DRUG: Gemcitabine + Carboplatin Chemotherapy Agents DRUG: Pemetrexed + Cisplatin Chemotherapy Agents DRUG: Pemetrexed + Carboplatin Chemotherapy Agents BIOLOGICAL: Tremelimumab
Key outcome parameters	Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
Key inclusion criteria	For inclusion in the study, patients should fulfill the following criteria: Aged at least 18 years Documented evidence of Stage IV NSCLC No sensitizing EGFR mutation or ALK rearrangement No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC World Health Organization (WHO) Performance Status of 0 or 1
Key exclusion criteria	Patients should not enter the study if any of the following exclusion criteria are fulfilled: Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]
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