UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050478 |
|---|---|
| Receipt number | R000057398 |
| Scientific Title | A prospEctive observatioNal study evaluating profiling of T cell binding to anti-PD-1 antibody using peripHeral blood as signAture for tumor respoNse during ramuCirumab and docEtaxel afteR anti-PD-1 antibody |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2025/04/28 10:02:23 |
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Basic information
Public title
A prospEctive observatioNal study evaluating profiling of T cell binding to anti-PD-1 antibody using peripHeral blood as signAture for tumor respoNse during ramuCirumab and docEtaxel afteR anti-PD-1 antibody
Acronym
ENHANCER study
Scientific Title
A prospEctive observatioNal study evaluating profiling of T cell binding to anti-PD-1 antibody using peripHeral blood as signAture for tumor respoNse during ramuCirumab and docEtaxel afteR anti-PD-1 antibody
Scientific Title:Acronym
ENHANCER study
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 the anti-tumor effects of ramucirumab (RAM) + docetaxel (DOC) after anti-PD-1 (Programmed death-1) antibody in terms of peripheral blood T-cell subsets in patients with previously treated advanced or recurrent non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the expression rate of various markers such as activated/exhausted/proliferation of T cells binding to anti-PD-1 antibody before and after administration of RAM + DOC
Key secondary outcomes
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with advanced or recurrent non-small cell lung cancer (histology or cytologically confirmed NSCLC)
2. Patients who have experienced progression disease after nivolumab or pembrolizumab treatment
3. Patients receiving ramucirumab plus docetaxel as second or subsequent therapy to anti-PD-1 antibody
4. Patients with at least one measurable lesion
5. Patients aged over 18 years old
6. Patients with a performance status of 0 or 1
7. Patients with preserved organ function enough to receive RAM plus DOC
Neutrophil count >1,500 /uL
Hemoglobin >9.0 g/dL (5.58 mmol/L)
Platelet count >105 /uL
Total bilirubin <1.5 times the upper limit normal (ULN)
AST and ALT < 3.0 times the ULN or 5.0 times the ULN in the setting of liver metastases
Creatinine < 1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) > 40 mL/minute
International Normalized Ratio (INR) < 1.5 ULN
INR < 1.5, and APTT < 5 seconds above the ULN (unless receiving anticoagulation therapy and patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy)
Urine protein less than 1+ (if 2+, urine protein creatinine ratio < 1.0 or protein/24 h < 1 g)
Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose of protocol therapy
8. Asymptomatic and without ongoing requirement for corticosteroids or the other medication as a therapy for CNS disease
9. Patients who are eligible to give consent for this clinical research
Key exclusion criteria
1. Patients who have received ipilimumab as a previous therapy
2. Patients receiving more than steroids equivalent to 10 mg of prednisone per day
3. Patients who are judged by the attending physician to be ineligible for this study
Obvious invasion into the main bronchus
Obvious intratumor cavitation on imaging
Obvious involvement of major thoracic vessels with risk of major hemorrhage
Hemoptysis of more than 5 ml within 2 months (blood sputum is acceptable)
History of gastrointestinal perforation/fistula or risk factors for perforation/fistula within 6 months
Grade 3-4 gastrointestinal bleeding within 3 months
Major surgery within 1 month or evidence of severe unhealed wound or minor surgery/subcutaneous venous access device placement within 7 days or bone fractures within 28 days
Hypertension completely uncontrolled by medication (systolic >150 mmHg, diastolic >90)
Presence of severe (Child-Pugh B or higher, hepatic encephalopathy) cirrhosis or clinically meaningful ascites resulting from cirrhosis
Deep vein thrombosis, pulmonary embolism, or other thrombosis within 3 months
Arterial thromboembolic event such as myocardial infarction, transient ischemic attack, cerebrovascular disease, or unstable angina within 6 months
Receipt of chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents (325mg daily aspirin is permitted)
Reproductive precautions; the patient is pregnant or breast-feeding
4. Patient is unable to give his/her consent
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Shiroyama |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
shiroyamat@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kinnosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3831
Homepage URL
m.kinnosuke@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan
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
Osaka University Institutional Review Board
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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 | 03 | Month | 03 | 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
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057398
