UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029576
Receipt number 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 2021/10/08 17:13:58

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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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

Completed

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

2021 Year 10 Month 08 Day



Link to view the page

Value
https://center6.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