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

Conditions

• High-Risk Resectable NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Sintilimab, Tislelizumab, Durvalumab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2018

Status verified

Oct 2021

Primary completion

Mar 23, 2023

Completion

Mar 23, 2023

Study Design

Enrollment

27 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Single arm

Primary Outcome Measure

Safety and Adverse effects [ Time Frame: 8 weeks ]