JPRN-jRCTs031200021进行中（未招募）2 期
A Randomized Phase II trial of afatinib switching to osimertinib versus osimertinib as first-line treatment in advanced NSCLC patients with EGFR mutation (TORG1939/WJOG12919L)
Yoshioka Hiroshige0 个研究点目标入组 110 人开始时间: 2020年4月22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
- 110
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 with non-squamous NSCLC pathologically confirmed
- •2. Non-curable clinical stage IIIB, IIIC, IV, or postoperative recurrence
- •3. Patients with EGFR gene mutation positive (Exon19 deletion mutation (Exon19del) or Exon21 point mutation (L858R))
- •4. The patient has been fully informed of the disease name and condition by the doctor in advance
- •5. Patients who have not received anticancer treatment with cytotoxic anticancer drugs, molecular targeted drugs, and immune checkpoint inhibitors
- •6. The age at the time of obtaining consent is over 20 years old
- •7. ECOG Performance status (PS) is 0-1
- •8. Main organ functions are maintained
- •9. QTc: <= 480 msec
- •10. Having a measurable lesion or an evaluable unmeasurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1
- •11. Expected to survive for more than 3 months
- •12. Patients have given written informed consent after the study has been fully explained prior to enrollment
排除标准
- •1. Patients with a history of drug-induced lung injury or patients with interstitial pneumonia that is evident on chest CT
- •2. Patients with symptomatic brain metastases.
- •3. Patients with meningeal carcinomatosis
- •4. Patients with spinal metastases that require radiation therapy or surgery
- •5. Patients with pleural effusion, ascites or pericardial effusion that require drainage
- •6. Patients who received radiation therapy including lungs within 14 days prior to registration (including palliative radiation therapy)
- •7. Patients with active multiple primary cancer
- •8. Patients with local or systemic active infections that require treatment
- •9. Pregnant, breastfeeding, women who may be currently pregnant, or patients who are not willing to contraceptive
- •10. Patients judged to be difficult to enroll in this study due to clinically problematic psychiatric / neurological disorders
- •11. Patients receiving continuous systemic administration of steroids (low-dose steroids (up to 10 mg prednin equivalent) or immunosuppressants)
- •12. Patients with a history of severe hypersensitivity
- •13. Patients with clinical complications (such as poorly controlled heart, lung, liver, kidney disease, diabetes, etc.)
- •14. Other patients who are judged inappropriate by the doctor in charge
- •* 1 Active double cancer is synchronous double cancer and metachronous double cancer with a disease-free period of 5 years or less, equivalent to carcinoma in situ (carcinoma in situ) or carcinoma in mucosa, which is judged to be cured by local treatment Lesions should not be included in active double cancer
- •* 2 Handling of hepatitis virus infection is as follows.
- •1)HBc antibody and / or HBs antibody positive and less than HBV-DNA 1.3 Log IU / mL (20 IU / mLl): qualified. However, litigation treatment should be performed with careful monitoring of HBV-DNA.
- •2) HBV antibody and / or HBs antibody positive and HBV-DNA 1.3 Log IU / mL (20 IU / mL1) or more: Eligible for cases where nucleic acid analog prophylaxis is being administered appropriately. In that case, litigation treatment should be performed with careful monitoring of HBV-DNA.
- •3) HBsAg positive: Not qualified
研究者
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