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Completed

NCT Number: NCT04047186

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tislelizumab Injection

Drug

Patients in the experimental group receive Tislelizumab Injection

Primary outcomes

  1. Objective Response Rate

    Time frame: twelve weeks

Secondary outcomes

  1. treatment-related adverse events

    Time frame: three months

Sponsors and collaborators

Lead sponsor

XiangNing Fu

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 6, 2019
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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