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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)

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ClinicalTrials.gov Identifier: NCT02453282
Recruitment Status : Active, not recruiting
First Posted : May 25, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1118 participants
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)
Actual Study Start Date : July 21, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. The efficacy of durvalumab monotherapy compared to SoC in terms of Objective Response Rate (ORR) or Progression-Free Survival (PFS) [ Time Frame: 3 years ]
  2. The efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR) [ Time Frame: 3 years ]

Other Outcome Measures:
  1. 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 ]


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453282


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Ho Chi Minh, Vietnam
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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02453282     History of Changes
Other Study ID Numbers: D419AC00001
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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