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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02453282
First received: May 20, 2015
Last updated: May 1, 2017
Last verified: April 2017
  Purpose
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

Condition Intervention Phase
Non-Small-Cell Lung Carcinoma NSCLC Biological: MEDI4736 (Durvalumab) Biological: MEDI4736 (Durvalumab)+Tremelimumab Drug: Paclitaxel + Carboplatin Drug: Gemcitabine + Cisplatin Drug: Gemcitabine + Carboplatin Drug: Pemetrexed + Cisplatin Drug: Pemetrexed + Carboplatin Biological: Tremelimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Progression-Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC [ Time Frame: 3 years ]
  • The efficacy of durvalumab therapy compared to SoC in terms of Overall Survival (OS) in patients with NSCLC [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • The efficacy of durvalumab monotherapy compared to SoC in terms of Objective Response Rate (ORR) or Progression-Free Survival (PFS) [ Time Frame: 3 years ]
  • The efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR) [ Time Frame: 3 years ]

Other Outcome Measures:
  • The safety and tolerability profile of durvalumab + tremelimumab combination therapy and durvalumab monotherapy compared to SoC will be determined using vital signs, laboratory data, electrocardiograms (ECGs), and physical examination [ Time Frame: 3 years ]

Enrollment: 1118
Actual Study Start Date: July 21, 2015
Estimated Study Completion Date: June 14, 2018
Estimated Primary Completion Date: June 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy
PD-L1 monoclonal Antibody monotherapy.
Biological: MEDI4736 (Durvalumab)
Experimental: Combination Therapy
PD-L1+Tremelimumab combination therapy
Biological: MEDI4736 (Durvalumab)+Tremelimumab Biological: Tremelimumab
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
  2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
  3. 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
  4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02453282

  Show 167 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stuart McIntosh, MD AstraZeneca, Alderley Park, Cheshire, UK
Principal Investigator: Naiyer Rizvi, MD Columbia University Medical Center, New York, NY, USA
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02453282     History of Changes
Other Study ID Numbers: D419AC00001
Study First Received: May 20, 2015
Last Updated: May 1, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
NSCLC, PD-L1, MEDI4736, Tremelimumab, PFS, OS

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Tremelimumab
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017