UMIN-CTR Clinical Trial

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 Yoshitaka Middle name Last name Zenke
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code	277-8577
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 Shinichiro Middle name Last name Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code	556-0016
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	National Cancer Center Hospital East Certified Review Board
Address	6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
Tel	04-7133-1111
Email	ncche-irb(at)east.ncc.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	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	Completed
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	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035952