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

Sponsor

Tongji Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04047186

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Pulmonary Nodules	Drug: Nivolumab Injection	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: neoadjuvant PD-1 group

receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor

Drug: Nivolumab Injection

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

Outcome Measures

Primary Outcome Measures

pathological response rate [one month]

Secondary Outcome Measures

treatment-related adverse events [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital Affiliated to Huazhong Technology Hospital	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tongji Hospital

ClinicalTrials.gov Identifier:

NCT04047186

Other Study ID Numbers:

2019CR107

First Posted:

Aug 6, 2019

Last Update Posted:

Aug 6, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Tongji Hospital

immunotherapy

Multiple Pulmonary Nodules

Lung Neoplasms

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Nivolumab

Study Results

No Results Posted as of Aug 6, 2019