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

NCT04047186 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2019CR107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Pulmonary Nodules

Keywords

immunotherapy; Multiple Pulmonary Nodules; Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  twelve weeks

Secondary Outcomes (1)

• treatment-related adverse events

  three months

Study Arms (1)

neoadjuvant PD-1 group

EXPERIMENTAL

receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor

Drug: Tislelizumab Injection

Interventions

Tislelizumab Injection DRUG

Patients in the experimental group receive Tislelizumab Injection

neoadjuvant PD-1 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XiangNing Fu: lead

Study Sites (1)

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Lung Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: May 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)