Back to resultsNeoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
Primary Purpose
Multiple Pulmonary Nodules
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nivolumab Injection
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Pulmonary Nodules focused on measuring immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms
Eligibility Criteria
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
Sites / Locations
- Tongji Hospital Affiliated to Huazhong Technology Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neoadjuvant PD-1 group
Arm Description
receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor
Outcomes
Primary Outcome Measures
pathological response rate
Secondary Outcome Measures
treatment-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04047186
Brief Title
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
Official Title
Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Pulmonary Nodules
Keywords
immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant PD-1 group
Arm Type
Experimental
Arm Description
receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injection
Intervention Description
Nivolumab 3mg/kg on day-28 and day-14 prior to planned surgical resection
Primary Outcome Measure Information:
Title
pathological response rate
Time Frame
one month
Secondary Outcome Measure Information:
Title
treatment-related adverse events
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangning Fu, MD
Phone
+8613607150390
Email
fuxn2006@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shu Peng, PhD
Phone
+8618571716422
Email
drpeng90@hotmail.com
Facility Information:
Facility Name
Tongji Hospital Affiliated to Huazhong Technology Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangning Fu, MD
Phone
0086-13607150390
Email
Fuxn2006@aliyun.com
First Name & Middle Initial & Last Name & Degree
Shu Peng, PhD
Phone
0086-18571716422
Email
drpeng90@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to regulation of institution, IPD can not be shared.
Learn more about this trial
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
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