UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047035 |
|---|---|
| Receipt number | R000053658 |
| Scientific Title | A Phase II Study of Anamorelin and Ipilimumab plus Nivolumab in non-small cell lung cancer (NSCLC) patients with Cancer Cachexia |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2025/03/12 09:26:28 |
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Basic information
Public title
Immunotherapy for Non-small Cell Lung Cancer Patients with Cancer Cachexia
Acronym
Cancer Cachexia and Immunotherapy
Scientific Title
A Phase II Study of Anamorelin and Ipilimumab plus Nivolumab in non-small cell lung cancer (NSCLC) patients with Cancer Cachexia
Scientific Title:Acronym
NEJ058A
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase 2 study investigating Anamorelin and Ipilimumab plus Nivolumab for patients with cancer cachexia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Response 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Anamorelin daily 100mg p.o.
2) Ipilimumab 1mg/Kg div, once 6 weeks
3) Nivolumab 120mg/week div, biweekly or triweekly
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically non-small cell lung cancer
(2) Negative for EGFR mutations and ALK mutations
(3) Stage 3B, 3C, 4A, or 4B or post operative recurrence
(4) ECOG performance status (PS) 0-1
(5) Cancer Cachexia
(6) 20-79 years old
(7) Adequate organ functions
1)Neutrophil count: more than 1,500/m3
2)Hb: more than 9.0g/dL
3)Platelet: more than 100,000/m3
4)AST: less than 2.5 folds of normal upper limit
5)ALT: less than 2.5 folds of normal upper limit
6)Total bilirubin: less than 1.5 folds of normal upper limit
7)Serum creatinine: less than 1.5mg/dL
8)SpO2: more than 95%
(8) Life expectancy: more than 12 weeks
(9) Obtained written informed consent
Key exclusion criteria
(1) Allergy for drugs used in this study
(2) Congestive heart failure, myocardial infarction, complete AV block etc, QTc longer than 470msec
(3) Contraindication drug for Anamorelin
(4) Double cancer
(5) Other cancer treatments such as cytotoxic drug, immunotherapy, biological drug, and hormone therapy
(6) Apparent interstitial lung disease (ILD) diagnosed by Chest X-ray
(7) Active B hepatitis
(8) Primary immunodeficiency
(9) Gastrointestinal obstruction, post total gastrectomy, active bowel inflammation such as Crohn disease and ulcerative colitis
(10) Sever complications
(11) Steroid treatment for more than 4 weeks
(12) Autoimmune disease
(13) Pregnancy and its possibilities
(14) Post organ implantation
(15) Other inappropriate conditions judged by doctors
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kisohara |
Organization
Kasukabe Medical Center
Division name
Department of Respiratory Medicine
Zip code
344-8588
Address
6-7-1 Chuo Kasukabe-City Saitama, Japan
TEL
048-735-1261
kisohara@kasukabe-city-hosp.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Odagiri |
Organization
NPO North East Japan Study Group
Division name
Secretary of NEJSG
Zip code
350-0451
Address
2F 1-113-1 Kishiki-cho omiya-ku Saitama-City, Japan
TEL
048-778-9521
Homepage URL
nejsg-dm@nejsg.jp
Sponsor or person
Institute
NPO North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
NPO North East Japan Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central IRB of Saitama Medical University
Address
38 Morohongo Moroyama-Town Iruma-gun, Saitama, Japan
Tel
049-276-1662
chuoirb@saitama-med.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
| 2022 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053658
