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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04047186

Enrollment

Registered

2019-08-06

Start date

2019-07-01

Completion date

2025-05-30

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Pulmonary Nodules

Keywords

immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms

Brief summary

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

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

Interventions

DRUGTislelizumab Injection

Patients in the experimental group receive Tislelizumab Injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective Response Rate	twelve weeks

Secondary

Measure	Time frame
treatment-related adverse events	three months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026