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

Multiple Pulmonary Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04047186
• Other study ID #: 2019CR107
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2019
• Source: Tongji Hospital
• Contact: Xiangning Fu, MD
• Phone: +8613607150390
• Email: fuxn2006[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Multiple Pulmonary Nodules

Intervention

Drug:
• Nivolumab Injection
Nivolumab 3mg/kg on day-28 and day-14 prior to planned surgical resection

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Huazhong Technology Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological response rate		one month
Secondary	treatment-related adverse events		one month