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

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

Detailed Description
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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

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

Conditions
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Multiple Pulmonary Nodules

Intervention / Treatment
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* Drug: Nivolumab Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neoadjuvant PD-1 group<br>receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor | Drug: Nivolumab Injection<br>* Nivolumab 3mg/kg on day-28 and day-14 prior to planned surgical resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological response rate |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment-related adverse events |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms