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

NCT03732664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-03-24

No results posted yet for this study

Summary

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.

Conditions

  • High-Risk Resectable NSCLC

Interventions

DRUG

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

One to four doses of anti-PD-1 or anti-PD-L1 antibody will be administered to enrolled patients on Day -56, Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732664 on ClinicalTrials.gov