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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035916
Receipt No. R000040910
Scientific Title A prospective multi-institutional observational study to explore novel biomarkers of chemo-radiation therapy combined with durvalumab to patients with unresectable stage III non-small cell lung cancer (WJOG11518L)
Date of disclosure of the study information 2019/02/18
Last modified on 2019/05/08

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Basic information
Public title A prospective multi-institutional observational study to explore novel biomarkers of chemo-radiation therapy combined with durvalumab to patients with unresectable stage III non-small cell lung cancer
(WJOG11518L)
Acronym A prospective multi-institutional observational study to explore novel biomarkers of durvalumab treatment in patients with stage III non-small cell lung cancer (WJOG11518L)
Scientific Title A prospective multi-institutional observational study to explore novel biomarkers of chemo-radiation therapy combined with durvalumab to patients with unresectable stage III non-small cell lung cancer
(WJOG11518L)
Scientific Title:Acronym A prospective multi-institutional observational study to explore novel biomarkers of durvalumab treatment in patients with stage III non-small cell lung cancer (WJOG11518L)
Region
Japan

Condition
Condition Locally advanced non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore potential biomarkers of durvalumab therapy combined with chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer, and suggest future treatment strategies.
Basic objectives2 Others
Basic objectives -Others To explore biomarkers
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Association of biomarkers with progression-free survival
Key secondary outcomes Association of biomarkers with overall survival, association of biomarkers with immune-related adverse event, association of biomarkers with response rate, association of biomarkers with disease control rate, cut-off values of biomarkers, association of biomarkers with immune-related gene expression, association among biomarkers

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) provision of written informed consent
2) age of 20 years old or older
3) pathological diagnosis of non-small cell lung cancer (not mucoepidermoid carcinoma, adenoid cystic carcinoma, and large cell neuroendocrine carcinoma)
4) provision of archival tumor tissue obtained prior to chemo-radiotherapy (10-25 slices [4 micro meters in thickness])
5) provision of peripheral blood sample before durvalumab therapy
6) locally advanced unresectable stage III non-small cell lung cancer according to version 8 TNM classification
7) no evidence of disease progression after definitive chemo-radiotherapy (>=54Gy of thoracic radiation therapy and 2 cycles of platinum based chemotherapy), and durvalumab therapy (10mg/kg every 2 weeks) is planned to start within 42 days after the last dose of radiation
8) ECOG PS of 0 or 1
Key exclusion criteria 1) previous treatment with PD-1 or PD-L1 inhibitor treatment
2) postoperative recurrence of non-small cell lung cancer
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Haratani
Organization Kindai University, Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2, Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL 072-366-0221
Email haratani_k@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
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 Astrazeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 11 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 04 Month 09 Day
Last follow-up date
2023 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study will evaluate the association of biomarkers from pretreatment archival tumor tissue samples and pretreatment peripheral blood samples, with the efficacy of durvalumab.

Management information
Registered date
2019 Year 02 Month 18 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040910

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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