臨床研究等提出・公開システム

Date of registration	June. 04, 2019
Last modified on	July. 06, 2022
Trial ID	jRCT2080224711

Scientific Title	A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer
Public Title	ORION

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	AstraZeneca
	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		April. 05, 2019
Target Sample Size		20
Study Type		Interventional
Study Design	Study Design	Randomized, multi-center, double-blind, global study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. - Patients must have tumors that lack activating EGFR mutations and ALK fusions. - (WHO)/(ECOG) performance status of 0 or 1 - No prior chemotherapy or any other systemic therapy for Stage IV NSCLC - Adequate organ and marrow function without blood transfusions in the past 28 days, - At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment - Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. - Creatinine Clearance (CrCl) 51 mL/min or more calculated by Cockcroft-Gault equation or measured by 24-hour urine collection. - Ability to swallow whole oral medications.
	Exclusion Criteria	- Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. - Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5' diphosphoribose [poly(ADP ribose)] polymerase(PARP) therapy, or immunomediated therapy Active or prior documented autoimmune or inflammatory disorders. - Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. - Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product(IP) - untreated(CNS) metastases and/or carcinomatous meningitis - Active infection. Exclusion criteria to be randomized to maintenance treatment: - Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Non-small Cell Lung Cancer NSCLC
Intervention(s)		investigational material(s) Generic name etc : Durvalmab, Olaparib INN of investigational material : durvalmab, olaparib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Durvalmab 1500 mg q3w (initial therapy phase) and 1500 mg q4w (maintenance phase) Olaparib Two x 150 mg olaparib tablets should be taken at the same time each day, approximately 12 hours apart with 1 glass of water control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Matching placebo for oral tablet BID
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy -
Secondary Outcome		safety exploratory -

Primary Sponsor	AstraZeneca KK
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IRB of Kurume University Hospital
Address of IRB	67 Asahimachi, Kurume-shi, Fukuoka
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Feb. 19, 2019

Secondary ID No.	NCT03775486
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194787
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/Europe

History of Changes

No	Publication date
4	July. 06, 2022	(this page)	Changes
3	April. 22, 2020	Detail	Changes
2	Mar. 03, 2020	Detail	Changes
1	June. 05, 2019	Detail

List of change history