JCOG2502: A randomized phase III trial comparing osimertinib and durvalumab following concurrent chemoradiotherapy for patients with unresectable locally advanced non-small cell lung cancer harboring EGFR mutations (ODYSSEIA)

未提供0 个研究点目标入组 160 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 160

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•(1) Histologically or cytologically proven non-small cell lung cancer (NSCLC).
•(2) Presence of activating EGFR mutations, defined as an exon 19 deletion or an exon 21 L858R point mutation.
•(3) Not judged as progressive disease (PD) according to the RECIST criteria, based on comparison between pre-chemoradiotherapy (CRT) contrast-enhanced chest and abdominal CT and post-CRT imaging. In addition, no evidence of brain metastases on post-CRT contrast-enhanced brain MRI or CT.
•(4) Unresectable locally advanced NSCLC, treated with definitive concurrent CRT, that met all of the following criteria (a)-(c). Patients with postoperative recurrence are not eligible.
•(a) Diagnosed as clinical stage IIB with N2a disease or clinical stage III before concurrent CRT (UICC-TNM 9th edition).
•(b) Concurrent CRT must meet all of the following criteria (i)-(iii).
•(i) Chemotherapy, satisfying one of the following:
•At least one cycle of platinum-based chemotherapy regimen with a planned course length of 3 or 4 weeks.
•At least three cycles of platinum-based chemotherapy regimen with a planned course length of 1 week.
•Low-dose carboplatin administered >=10 times.
•(ii) RT: a total dose of 60 Gy +-10% (range, 54-66 Gy) with lung V20 <35%.
•(iii) Concurrency: chemotherapy and RT administered concurrently, with any period of overlap.
•(c) No consolidation chemotherapy administered after completion of RT.
•(5) Aged 18 years or older.
•(6) ECOG performance status 0-
•(7) Presence of measurable lesions is not mandatory.
•(8) No Grade 2 or higher pneumonitis attributable to concurrent CRT.
•(9) Post-CRT period within 42 days after completion of RT.
•(10) No prior treatment with anti-PD-1, anti-PD-L1 antibodies or EGFR-TKIs for any cancer.
•(11) No active autoimmune disease and no history of chronic or recurrent autoimmune disease.
•(12) QTc interval <480 ms on an electrocardiogram performed within 28 days before the enrollment.
•(13) Sufficient organ function, assessed within 14 days before the enrollment, as follows:
•(i) Neutrophil count >= 1,000 /mm3
•(ii) Hemoglobin >= 8.0 g/dL
•(iii) Platelet count >= 75,000 /mm3
•(iv) T-bil <= 1.5 mg/dL
•(v) AST <= 100 U/L
•(vi) ALT <= 100 U/L
•(vii) Serum creatinine <= 2.0 mg/dL
•(viii) Oxygen saturation level (SpO2) >= 92%
•(14) Written informed consent.

排除标准

•(1) Simultaneous or metachronous (within five years) double cancers, with the exception of intramucosal tumor curable with local therapy.
•(2) Active infection requiring systemic therapy.
•(3) Fever over 38 degrees Celsius.
•(4) Female during pregnancy, within 28 days of post parturition, or during lactation.
•(5) Psychological disorder difficult to participate in this clinical study.
•(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
•(7) Uncontrolled diabetes mellitus.
•(8) History of unstable angina pectoris within three weeks or myocardial infarction within 6 months before the enrollment.
•(9) Uncontrolled heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
•(10) Positive for HIV antibody.
•(11) Interstitial pneumonia and/or pulmonary fibrosis diagnosed on chest CT before initiation of concurrent CRT.

研究者

发起方

未提供

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