RAM+DOC vs Atezo (EMERALD study)

JRCT ID: jRCTs031180363

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 25/06/2018
• Target sample size: 420
• Study type: Interventional

Intervention(s)

1.Atezolizumab every 3 weeks iv.
2.Doccetaxel+Ramucirumab every 3 weeks iv.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, response rate, duration of response, safety, rate of receiving crossover treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Cytologically or histologically confirmed non-small cell lung cancer.
2) TPS<=49% has been confirmed with a test with PD-L1 IHC22C3 pharmDx using tissue samples.
3) Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease.
4) Aged 20 or older
5) Have received a regimen of platinum-based therapy as a pre-treatment (without docetaxel)
6) 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 costimulatory pathway or checkpoint pathway.
7) Performance status (PS) is 0 or 1 in ECOG criteria.
8) Patients who are expected to live for at least three months.
9) No active hepatitis B infection.
10)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).
11) No symptomatic brain metastasis, or spinal metastasis requiring radiation or surgical treatment.
12) No symptomatic superior vena cava syndrome.
13) No pericardial effusion, pleural effusion, or ascites that cannot be controlled.

Exclude 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 anappropriate 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)

Related Information

• Primary Sponsor: Tsuboi Masahiro
• Secondary Sponsor: Zenke Yoshitaka
• Source(s) of Monetary Support: Eli Lilly Japan K.K. All
• Secondary ID(s): UMIN000031584