Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules

Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study

Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study

Study Overview

• Status: Completed
• Conditions: Multiple Pulmonary Nodules
• Intervention / Treatment: Drug: Tislelizumab Injection

Detailed Description

In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huazhong Technology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• not less than two GGNs on chest CT
• at least one lesion is diagnosed as NSCLC from biopsy pathology
• no contraindication for surgery
• ECOG score of 0 or 1
• no detectable evidence of distant metastasis

Exclusion Criteria:

• medical history of malignancy
• pregnant or breeding period
• severe organ failure (heart, liver, kidney, and lung)
• high risk of cerebral-cardiovascular evens
• infection out of control
• received or receiving chemo- and radiotherapy
• history of severe reaction due to allergy or hypersensitivity
• severe mental disorder
• currently been enrolled in other trials
• autoimmune or chronic inflammatory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoadjuvant PD-1 group; receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor	Drug: Tislelizumab Injection; Patients in the experimental group receive Tislelizumab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	twelve weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
treatment-related adverse events	three months

Collaborators and Investigators

• Sponsor: XiangNing Fu

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: August 4, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; Lung Neoplasms; Multiple Pulmonary Nodules
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; tislelizumab
• Other Study ID Numbers: 2019CR107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to regulation of institution, IPD can not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes