NCT02453282

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)

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).

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,118 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Non-Small-Cell Lung Carcinoma NSCLC

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-21
• Primary completion: 2018-10-04
• Completion: 2026-12-31
• First posted: 2015-05-25
• Last updated: 2026-03-02
• Results posted: 2019-11-29

Locations

196 sites across 17 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, Vietnam

Regulatory

• FDA-regulated drug study