UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L)
Title of the study (Brief title)	A phase III study of Platinum doublet chemotherapy +/- Nivolumab in advanced non-small cell lung cancer (WJOG8615L)
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate whether platinum doublet chemotherapy plus nivolumab prolong PFS and OS compared with platinum doublet chemotherapy in chemo-naive advanced NSCLC
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival and progression-free survival
Key secondary outcomes	Overall response rate, survival rate at two years, and safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Platinum doublet chemotherapy (cisplatin 75mg/m2, or carbploatin (AUC 6)+pemetrexed 500mg/m2, cisplatin 75mg/m2+gemcitabine 1000mg/m2, carboplatin (AUC 6)+paclitaxel 200mg/m2), 4 courses, every 3weeks
Interventions/Control_2	Platinum doublet chemotherapy (same as described above)+ nivolumab 3mg/kg, every 3 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Pathologically proven, advanced NSCLC 2. Chemotherapy-naive 3. With evaluable lesion per RECIST ver 1.1 4. Tumor specimen can be submitted to evaluate PD-L1 IHC 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Key exclusion criteria	1. Subjects with active, known or suspected autoimmune disease. 2. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization 3. Subjects with interstitial lung disease 4. Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection
Target sample size	530

Research contact person
Name of lead principal investigator	Hiroaki Akamatsu
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL	073-441-0619
Email	h-akamat@wakayama-med.ac.jp

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd Bristol-Myers K.K
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2016 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024157