Window of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE)

Yonsei University1 个研究点分布在 1 个国家目标入组 25 人2022年9月1日

适应症Non Small Cell Lung Cancer

干预措施durvalumab

概览

阶段: 2 期
干预措施: durvalumab
疾病 / 适应症: Non Small Cell Lung Cancer
发起方: Yonsei University
入组人数: 25
试验地点: 1
主要终点: Major pathologic response
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is phase II, open label, clinical trial of durvalumab to identify immune dynamics in operable non-small cell lung cancer.

详细描述

In this study, the investigators plan to administer neoadjuvant durvalumab and adjuvant durvalumab to the operable NSCLC patients (resectable stage IIA\~IIIB) regardless of PD-L1 status. Durvalumab 1500mg IV will be administered once prior to surgery. Within 1-8 weeks after completion of durvalumab, patients will undergo surgery. Regardless of MRD status, patients will receive adjuvant treatment of durvalumab 1500mg IV q3 weeks with SoC platinum-based chemotherapy for a total of 4 cycles. \*\* Adjuvant chemotherapy will be based on standard of care treatment: navelbine 20mg/m2 (D1, 8) and cisplatin 80mg/m2 (D1) (q3w x 4 cycles). Thereafter, patients will be administered with adjuvant durvalumab 1500mg IV q4 weeks for 10 cycles

注册库

clinicaltrials.gov

开始日期

2022年9月1日

结束日期

2028年7月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Yonsei University

责任方

Principal Investigator

主要研究者

Chang Gon Kim

Principal Investigator

Yonsei University

入排标准

入选标准

•Histologically confirmed operable NSCLC (resectable stage IIA\~IIIB) regardless of PD-L1 expression.
•At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to neoadjuvant durvalumab.
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
•Male or female, 18 years or older (at the consent is obtained). Note: In the Republic of Korea, a participant must be over 19 years of age inclusive, at the time of signing the informed consent.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy of \> 12 weeks
•Body weight \>30 kg
•Adequate normal organ and marrow function as defined below:
•Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1.0 × 109 /L Platelet count ≥75 × 109/L Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
•AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN

排除标准

•Patients with EGFR mutations (identified with local testing).
•Any prior treatment for NSCLC, including prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody, chemo, RT, target therapy or investigational drug.
•Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
•Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria A. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
•B. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
•Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
•Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
•History of allogenic organ transplantation.
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
•A. Patients with vitiligo or alopecia B. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement C. Any chronic skin condition that does not require systemic therapy D. Patients without active disease in the last 5 years may be included but only after consultation with the study physician E. Patients with celiac disease controlled by diet alone

研究组 & 干预措施

durvalumab

The operable non-small cell lung carcinoma patients (resectable stage IIA\~IIIB)

干预措施: durvalumab

结局指标

主要结局

Major pathologic response

时间窗: Right after the surgery

Evaluate the pathologic response in resected tumor tissue. The major pathologic response is defined as less than 10% viable tumors after treatment.

次要结局

Disease-free survival(UP to 3years)
Overall survival (OS)(Up to 5years)
Distant metastases free survival(UP to 3years)
Minimal residual disease(At screening, Post neo-adjuvant durvalamab (+ 1 week ~ prior to surgery), Post-op (3-4 weeks after surgery), Post-op at 3 months (+/- 7 days), Post-op at 6 months (+/- 7 days), After progression (+/- 7 days))
Locoregional control(UP to 2years)