UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050878 |
|---|---|
| Receipt number | R000057983 |
| Scientific Title | Prospective observational study to evaluate the efficacy of anamorelin on the course of first line chemotherapy in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B) |
| Date of disclosure of the study information | 2023/04/18 |
| Last modified on | 2024/04/18 11:02:50 |
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Basic information
Public title
Prospective observational study to evaluate the efficacy of anamorelin on the course of first line chemotherapy in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
Acronym
Prospective observational study of anamorelin in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
Scientific Title
Prospective observational study to evaluate the efficacy of anamorelin on the course of first line chemotherapy in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
Scientific Title:Acronym
Prospective observational study of anamorelin in patients with previously-untreated advanced non-small cell lung cancer and cachexia (NEJ050B)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether anamorelin affects on Quality of Life (QOL) related to appetite, efficacy of first line chemotherapy, and adverse events on the course of first-line chemotherapy in patients with previously-untreated advanced non-small cell lung cancer and cachexia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with clinically relevant improvement in FAACT (A/CS) at 3 weeks after the start of first-line chemotherapy
Key secondary outcomes
FAACT (A/CS), Questionnaire for eating-related distress among patients with advanced cancer (QERD), FACT-G, ECOG PS, KPS, body weight, objective response rate, disease control rate, progression-free survival, overall survival, adverse events, Composite Clinical Response (defined as the proportion of patients with an increase in body weight of >= 5 % and an increase in FAACT 5IASS score of >= 2 points at 3 weeks after the start of first-line chemotherapy)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Pathologically diagnosed NSCLC.
(2) Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC.
(3) Subjects meet the diagnostic criteria for cachexia (body weight loss >= 5 % within the last 6 months).
(4) Subjects have anorexia and 2 or more of the following (i) to (iii): (i) have fatigue or malaise, (ii) have reduced overall muscular strength, (iii) have more than 1 of the following conditions: CRP > 0.5 mg/dL, Hb < 12 g/dL, Alb < 3.2 g/dL.
(5) No prior systemic therapy (including in cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitor) for advanced NSCLC. Subjects who received prior adjuvant and/or neo-adjuvant therapies are eligible.
(6) Subjects scheduled to receive systemic therapy (cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitor are all acceptable).
(7) Patients scheduled to receive anamorelin within 7 days prior to systemic therapy.
(8) ECOG PS of 0 to 2.
(9) Aged 18 years or more.
(10) Provided Informed Consent.
Key exclusion criteria
(1) Current use of corticosteroids.
(2) Subjects scheduled to receive systemic therapy, but don't fit into cohorts 1, 2, or 3.
(3) Subjects with a history of hypersensitivity to anamorelin
(4) Subjects with congestive heart failure
(5) Subjects with myocardial infarction or angina pectoris
(6) Subjects with severe conduction system disorders (such as complete atrioventricular block)
(7) Subjects receiving the following drugs: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products
(8) Subjects with liver dysfunction of more than moderate severity (Child-Pugh class B or C)
(9) Subjects with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormality of the gastrointestinal tract
(10) Subjects who are unable to accurately complete the QOL questionnaire.
(11) Subjects who are judged by the principal or sub-investigator to be unsuitable for inclusion in this study.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
kztakaha@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Miura |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ke.miura@scchr.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.ac.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
| 2023 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057983
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