臨床研究等提出・公開システム

Date of registration	Nov. 12, 2015
Last modified on	June. 16, 2020
Trial ID	jRCT2080223013

Scientific Title	A Phase 3 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)
Public Title	MYSTIC

Completion Date or Terminated date	April. 03, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address
	Phone Number
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Recruitment Status	completed

Date of First Enrolment		Dec. 02, 2015
Target Sample Size		74
Study Type		Interventional
Study Design	Study Design	Randomized, Parallel Assignment
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- 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	- 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]
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Non-Small-Cell Lung Carcinoma (NSCLC)
Intervention(s)		investigational material(s) Generic name etc : MEDI4736(Durvalumab), MEDI4736(Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin, Pemetrexed + Cisplatin, Pemetrexed + Carboplatin, Tremelimumab INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : For adult patients, Durvalumab 20 mg/kg and Tremelimumab 1 mg/kg via IV infusion every 4 weeks (q4w) up to a total of 4 doses/cycles, and then continue Durvalumab 20 mg/kg via IV infusion q4w. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy confirmatory pharmacogenomics -
Secondary Outcome		safety efficacy confirmatory exploratory pharmacokinetics pharmacogenomics -

Primary Sponsor	AstraZeneca
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Hospital Organization Iwakuni Clinical Center IRB
Address of IRB	1-1-1, Atagomachi, Iwakuni-shi, Yamaguchi, 740-8510
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Dec. 10, 2015

Secondary ID No.	NCT02453282
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-153067
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
9	June. 16, 2020	(this page)	Changes
8	Dec. 17, 2018	Detail	Changes
7	Feb. 23, 2017	Detail	Changes
6	Feb. 23, 2017	Detail	Changes
5	June. 30, 2016	Detail	Changes
4	June. 06, 2016	Detail	Changes
3	June. 06, 2016	Detail	Changes
2	Nov. 12, 2015	Detail	Changes
1	Nov. 12, 2015	Detail

List of change history