JPRN-jRCTs051200138进行中（未招募）2 期
Multicenter Phase II Study of Cisplatin, Gemcitabine, and Necitumumab in Patients with Unresectable, Advanced or Recurrent Squamous Cell Carcinoma of the Lung Who Have Failed on or Relapsed after Initial Treatment with a Combination of Immune Checkpoint Inhibitors and Platinum based Chemotherapy: NESSIE study - NESSIE study (WJOG14120L)
Yoshioka Hiroshige0 个研究点目标入组 45 人开始时间: 2021年2月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
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
- •All of the following conditions must be satisfied
- •1. Patients have given written informed consent after the study has been fully explained prior to enrollment
- •2. The age at the time of obtaining consent is 20 years or older
- •3. Patients with histologically or cytologically confirmed squamous cell carcinoma
- •4. Inoperable clinical stage IIIB, IIIC, IV, or postoperative recurrence*
- •*Recurrence after stereotactic radiotherapy in early lung cancer (cT1-2N0M0) is eligible.
- •5. Patients with a measurable lesion by RECIST ver. 1.1
- •6. Patients without symptomatic superior vena cava (SVC) syndrome
- •7. Patients without symptomatic brain metastasis nor brain metastasis requiring treatment
- •8. Radiotherapy-naive patients to lesions except for brain; following conditions are exceptionally permitted.
- •a. Palliative radiotherapy outside of the lung terminated more than 7 days before registration.
- •b. Post-operative radiotherapy before initial recurrence.
- •c. Definitive chemo-radiotherapy for initial treatment
- •d. Stereotactic radiotherapy in early lung cancer (cT1-2N0M0)
- •9. Patients without uncontrollable effusion
- •10. Patients who have failed on or relapsed after initial treatment with a combination of immune checkpoint
- •inhibitors and platinum based chemotherapy or definitive chemo-radiotherapy following durvalumab maintenance therapy.
- •11. Patients who received only one prior regimen which includes definitive chemo-radiotherapy following durvalumab maintenance therapy.
- •12. Patients with no prior chemotherapy nor radiotherapy for other malignancies
- •13. No major surgery within 28 days before registration
- •14. No minor surgery within 7 days before registration
- •15. ECOG performance status (PS) of 0-1
- •16. Life expectancy of 12 weeks or longer
- •17. Patients who have recovered to grade 1 or less from the toxicity of prior treatment with a combination of immune checkpoint inhibitors and platinum-based chemotherapy
- •18. No radiation pneumonitis or stable radiation pneumonitis grade 1 or less on registraion if patients received any previous radiotherapy including lung field.
- •19. Adequate organ function
- •20. Patients who have no HBs antigen nor antibody to HBV
- •21. Patients who are willing to abide by contraception
排除标准
- •Patients are ineligible if any one of following conditions is applicable.
- •1. Patients with active double cancer
- •2. Patients receiving continuous systemic administration of steroids (10mg prednisolone equivalent or more) or immunosuppressants
- •3. Patients with diabetes mellitus requiring insulin injection
- •4. Patients with uncontrollable thromboembolic disease
- •5. Patients with clinically important interstitial pneumonitis or pulmonary fibrosis, or history of interstitial pneumonitis on imaging studies
- •6. Patients who have severe coronary disease, uncontrollable congestive heart failure, or uncontrollable arrhythmia
- •7. Patients with angina pectoris or myocardial infarction within 6 months before registration
- •8. Patients with uncontrollable hypertension despite antihypertensive treatment
- •9. Patients with severe liver cirrhosis
- •10. Patients with a history of severe hypersensitivity to any study drug
- •11. Patients with local or systemic active infections that require treatment
- •12. Patients judged to be difficult to enroll in the study due to clinically problematic psychiatric / neurological disorders
- •13. Patients who are participating in other clinical trials which are competing against the study
- •14. Pregnant women, women under breastfeeding, or women who may be currently pregnant
- •15. History of drug abuse
- •16. Patients who are judged inappropriate to enroll the study by the doctor in charge
研究者
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