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ICIs Neoadjuvant Therapy in Resectable Non-Small-Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

ICIs Neoadjuvant Therapy in Resectable Non-Small-Cell Lung Cancer

NCT03732664•Second Affiliated Hospital, School of Medicine, Zhejiang University

Summary

Detailed Description

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 or anti-PD-L1 in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 or anti-PD-L1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven non-small-cell lung cancer (core biopsy required).
•* Squamous or non-squamous histology.
•* Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at The Second Affiliated Hospital Zhejiang University School of Medicine.
•* Either a formalin fixed paraffin block or a minimum of fifteen 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling). This can be obtained from archived tissues, or from a new biopsy if needed.
•Stage - High risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at The Second Affiliated Hospital Zhejiang University School of Medicine. This may include clinical stage IA3 (≥2cm), II and IIIA(see Appendix A). Subjects with N3 nodal involvement are not included.
•ECOG performance status 0-1.
•Adequate organ function as follows:
•* Leukocytes ≥ 2,000/mm3.
•* Absolute neutrophil count (ANC) ≥ 1000/mm3.
•* Platelet count ≥ 100,000/mm3.
+9 more criteria

Exclusion Criteria

•Subjects are excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
•Subjects are excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen.
•Administration of chemotherapy or any other cancer therapy in the pre-operative period.
•Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC (except non melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia).
•Subjects with brain metastasis are excluded from this study, and all patients should have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment.
•Subjects with a history of symptomatic interstitial lung disease.
•Active systemic infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
•Known positive history or positive test for Human Immunodeficiency Virus or
•Acquired ImmunoDeficiency Syndrome (AIDS).
•History of allergy to study drug components.
+5 more criteria

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

October 1, 2018

Primary Completion Date

March 23, 2023

Completion Date

March 23, 2023

Last Updated

March 24, 2023

Enrollment

ACTUAL participants

Conditions

High-Risk Resectable NSCLC

Interventions

Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Sintilimab, Tislelizumab, Durvalumab

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