UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031584
Receipt No. R000035952
Scientific Title Phase III study of ramucirumab plus docetaxel versus atezolizumab for PD-L1-negative or weakly positive advanced non-small-cell lung cancer after disease progression on platinum-based therapy. (EMERALD study) (WJOG10317L)
Date of disclosure of the study information 2018/03/05
Last modified on 2019/09/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase III study of ramucirumab plus docetaxel versus atezolizumab for PD-L1-negative or weakly positive advanced non-small-cell lung cancer after disease progression on platinum-based therapy. (EMERALD study) (WJOG10317L)
Acronym RAM+DOC vs Atezo (EMERALD study)(WJOG10317L)
Scientific Title Phase III study of ramucirumab plus docetaxel versus atezolizumab for PD-L1-negative or weakly positive advanced non-small-cell lung cancer after disease progression on platinum-based therapy. (EMERALD study) (WJOG10317L)
Scientific Title:Acronym RAM+DOC vs Atezo (EMERALD study)(WJOG10317L)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of ramucirumab plus docetaxel compared to atezolizumab for previously treated, PD-L1-negative or weakly positive advanced non-small-cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, response rate, duration of response, safety, rate of receiving crossover treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Atezolizumab 1,200 mg/body is administered every three weeks.
Interventions/Control_2 Docetaxel 60 mg/m2+ramucirumab 10 mg/kg are administered every three weeks.
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) Cytologically or histologically confirmed non-small cell lung cancer.
2) TPS<=49% has been confirmed with a test with PD-L1 IHC 22C3 pharmDx using tissue samples.
3) No EGFR gene mutation, ALK fusion gene, or ROS1 fusion gene.
4) Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease.
5) Aged 20 or older
6) At least one lesion measureable based on RECIST 1.1 Guideline.
7) Have received a regimen of platinum-based therapy as a pre-treatment (without docetaxel)
8) No history of treatment with anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies, or another antibody or agent that specifically targets the T-cell co-stimulatory pathway or checkpoint pathway.
9) Performance status (PS) is 0 or 1 in ECOG criteria.
10) Patients who are expected to live for at least three months.
11) No active hepatitis B infection.
12) It has been one week or more since a radiotherapy for metastasis (including gamma knife therapy for brain metastasis) (with the final day of the therapy as Day 1, it is Day 8 or more).
13) No symptomatic brain metastasis, or spinal metastasis requiring radiation or surgical treatment.
14) No symptomatic superior vena cava syndrome.
15) No pericardial effusion, pleural effusion, or ascites that cannot be controlled.
Key exclusion criteria 1) Active multiple primary cancers.
2) A history of autoimmune disease. However, the following cases are allowed to register.
-Controlled type 1 diabetes with stable insulin usage.
-Hypothyroidism that can be managed with hormone replacement therapy
3) Requires systemic adrenal steroid (equivalent of prednisone exceeding 10 mg/day) or another immunosuppressant within 14 days of the registration.
4) History of serious or non-healing wounds, ulcers, or fractures that are serious within 28 days before registration.
5) History of hypersensitivity to drugs containing polysorbate 80.
6) History of serious hypersensitivity.
7) Presence of local or systemic active infection
8) CT findings clearly show interstitial pneumonia.
9) Hemoptysis within two months of registration (>= 1/2 tsp).
10) History of digestive tract perforation, peptic ulcer, diverticulosis, or fistula within six months before registration.
11) History or the presence of intestinal obstruction, inflammatory bowel disorder, extensive intestinal resection (hemicolectomy or extensive small bowel resection due to chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
12) History of uncontrollable thrombosis or embolism.
13) Vasculitis, grade 3 or worse gastrointestinal bleeding, or clinically serious bleeding within three months of registration.
14) Arterial thrombosis such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within six months before trial treatment.
15) Congestive heart failure of New York Heart Association (NYHA) Class II or worse.
16) Diabetes that cannot be controlled even with an appropriate treatment.
17) Hypertension that cannot be controlled with a standard medical treatment (systolic blood pressure of 150 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher).
Target sample size 420

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Zenke
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577
TEL 04-7133-1111
Email yzenke@east.ncc.go.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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 02 Day
Date of IRB
2018 Year 03 Month 14 Day
Anticipated trial start date
2018 Year 03 Month 27 Day
Last follow-up date
2021 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.