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

Phase 2

Not yet recruiting

• Conditions: Multiple Pulmonary Nodules
• Interventions: Drug: Nivolumab Injection

• Registration Number: NCT04047186
• Lead Sponsor: Tongji Hospital

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

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-05
• Last Update Submitted: 2019-08-05
• Study First Posted: 2019-08-06
• Last Update Posted: 2019-08-06
• Study Start: 2019-10-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant PD-1 group	Nivolumab Injection	receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor

Primary Outcome Measures

Name	Time	Method
pathological response rate	one month

Secondary Outcome Measures

Name	Time	Method
treatment-related adverse events	one month

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Huazhong Technology Hospital; 🇨🇳 Wuhan, Hubei, China