UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035916 |
|---|---|
| Receipt number | 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 | 2023/12/07 15:17:57 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
143
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
| 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
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040910
