Unique ID issued by UMIN | UMIN000031584 |
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Receipt number | 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 | 2022/11/22 10:03:04 |
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)
RAM+DOC vs Atezo (EMERALD study)(WJOG10317L)
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)
RAM+DOC vs Atezo (EMERALD study)(WJOG10317L)
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
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.
Efficacy
Confirmatory
Phase III
Overall survival
Progression-free survival, response rate, duration of response, safety, rate of receiving crossover treatment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
Atezolizumab 1,200 mg/body is administered every three weeks.
Docetaxel 60 mg/m2+ramucirumab 10 mg/kg are administered every three weeks.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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).
420
1st name | Yoshitaka |
Middle name | |
Last name | Zenke |
National Cancer Center Hospital East
Department of Thoracic Oncology
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577
04-7133-1111
yzenke@east.ncc.go.jp
1st name | Shinichiro |
Middle name | |
Last name | Nakamura |
West Japan Oncology Group
WJOG datacenter
556-0016
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
Eli Lilly Japan
Profit organization
National Cancer Center Hospital East Certified Review Board
6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
04-7133-1111
ncche-irb(at)east.ncc.go.jp
NO
2018 | Year | 03 | Month | 05 | Day |
Unpublished
Completed
2018 | Year | 03 | Month | 02 | Day |
2018 | Year | 03 | Month | 14 | Day |
2018 | Year | 03 | Month | 27 | Day |
2021 | Year | 04 | Month | 19 | Day |
2018 | Year | 03 | Month | 05 | Day |
2022 | Year | 11 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035952
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