UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031584
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

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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 or person

Institute

West Japan Oncology Group

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

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

Value
https://center6.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