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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041778
Receipt No. R000047683
Scientific Title Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study
Date of disclosure of the study information 2020/11/15
Last modified on 2020/09/19

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Basic information
Public title Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study
Acronym OLCSG2001
Scientific Title Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study
Scientific Title:Acronym OLCSG2001
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to exploratoryly evaluate the efficacy and safety of immune checkpoint inhibitor(ICI)+ cytotoxic chemotherapy continuation after sequential radiation therapy in patients with advanced non-small cell lung cancer with Oligo-PD following induction therapy with combination with ICI and cytotoxic chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 sequential radiation therapy followed by immune checkpoint inhibitor(ICI)+ cytotoxic chemotherapy continuation
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 -The patient has histologically or cytologically confirmed non-small cell lung cancer.
-The patient has clinical stage III, IV, or post-operative recurrent non-small cell lung cancer that is not amenable to radical resection or radical radiation therapy.
-The patient has Oligo-PD after treatment with an immune checkpoint inhibitor (ICI) plus platinum-based cytotoxic anticancer agent.
<The Oligo-PD is defined as meeting all four of the following.>
1.Two or more courses of ICI+chemo induction and two or more courses of maintenance therapy, and tumor reduction of SD or greater with reduction.
2.The lesions that do not result in PD on RECIST as a whole if they are not exacerbated after ICI+chemo maintenance therapy and there is no exacerbation of the lesions.
3.The lesion must have no more than 3 lesions, including brain metastases, that are not in contact or fused by CT or MRI, respectively. However, lymph node metastases will be treated as a single lesion if the radiotherapist determines that the area can be irradiated at once.
4.Cases of cancerous pleural effusion, cancerous pericarditis, exacerbation in lymphangitis or cases of cancerous meningitis complications are excluded.
-All of these Oligo-PDs are capable of additional radiation exposure.
-An ECOG performance status (PS) of 0 to 1.
-Major organ function is intact.
-The patient is judged to be alive for at least 3 months from the date of enrollment.
Key exclusion criteria Patients with serious complications or history are excluded.
Target sample size 19

Research contact person
Name of lead principal investigator
1st name Daijiro
Middle name
Last name Harada
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of Thoracic Oncology
Zip code 791-0280
Address 160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
TEL 089-999-1111
Email harada.daijiro.kn@mail.hosp.go.jp

Public contact
Name of contact person
1st name Daijiro
Middle name
Last name Harada
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of Thoracic Oncology
Zip code 791-0280
Address 160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
TEL 089-999-1111
Homepage URL
Email harada.daijiro.kn@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Shikoku Cancer Center
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 National Hospital Organization Shikoku Cancer Center
Address 160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
Tel 089-999-1111
Email harada.daijiro.kn@mail.hosp.go.jp

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
2020 Year 11 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 24 Day
Last follow-up date
2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 13 Day
Last modified on
2020 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047683

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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