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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029576
Receipt No. R000033784
Scientific Title Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L)
Date of disclosure of the study information 2017/10/20
Last modified on 2019/07/17

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Basic information
Public title Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L)
Acronym chemotherapy after PD-1 inhibitors
Scientific Title Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L)
Scientific Title:Acronym chemotherapy after PD-1 inhibitors
Region
Japan

Condition
Condition advanced non-small cell 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 retrospective study is to investigate the efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall response rate of cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1
Key secondary outcomes Progression-free survival, overall survival and safety of cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically confirmed NSCLC
2. Stage III, IV or recurrence after curative radiotherapy or surgery according to the seventh edition of the TNM classification
3. Previously treated with cytotoxic chemotherapy as a first-line
1) Study arm: treated with nivolumab or pembrolizumab as a second-line and subsequently treated with cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1 as a third-line between December 1, 2015 and July 31, 2017
2) Control arm: treated with cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1 as a second-line between April 1, 2014 and July 31, 2017
Key exclusion criteria None
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Ryoji / Hidetoshi
Middle name
Last name Kato / Hayashi
Organization Kindai University Faculty of Medicine
Division name Department of Medical Oncology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL 072-366-0221
Email kato8560@gmail.com

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code 556-0016
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 None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Department of Medical Oncology, Kindai University Faculty of Medicine
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
Tel 072-366-0221
Email kato8560@gmail.com

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
2017 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 1626
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 10 Month 06 Day
Date of IRB
2017 Year 11 Month 02 Day
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective study will be performed based on the patient's clinical records.

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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