JPRN-jRCTs031180363已完成3 期
Phase III study of ramucirumab plus docetaxel versus atezolizumab for previously positive PD-L1-negative or weakly positive advanced non-small-cell lung cancer (WJOG10317L) - WJOG10317
Tsuboi Masahiro0 个研究点目标入组 70 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
We conducted a phase III trial to assess efficacy and safety of treatment with docetaxel plus ramucirumab or atezolizumab as 2nd-line treatment for PD-L1 negative or weakly positive patients with stage IV NSCLC after platinum-based chemotherapy.70 patients were enrolled and the study was terminated early due to slow accrual. The overall survival was not significantly different between two arms, although the docetaxel plus ramucirumab arm showed favorable overall response rate and progression-free survival.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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)
研究者
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