KCT0006973
Not yet recruiting
未知
Window of opportunity trial of durvalumab (MEDI4736) to identify immune dynamics in operable non-small cell lung cancer (NSCLC) (MIRACLE)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 25
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\. Histologically confirmed operable NSCLC (resectable stage IIA\~IIIB) regardless of PD\-L1 expression.
- •2\. 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.
- •3\. 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.
- •4\. 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.
- •5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6\. Life expectancy of \> 12 weeks
- •7\. Body weight \>30 kg
- •8\. Adequate normal organ and marrow function as defined below:
Exclusion Criteria
- •Exclusion Criteria:
- •1\. Patients with EGFR mutations (identified with local testing).
- •2\. 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.
- •3\. 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
- •4\. 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.
- •5\. 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.
- •6\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •7\. History of allogenic organ transplantation.
Outcomes
Primary Outcomes
Not specified
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