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

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ClinicalTrials.gov Identifier: NCT04047186
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Tongji Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
Drug Information available for: Nivolumab

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




Primary Outcome Measures :
  1. pathological response rate [ Time Frame: one month ]

Secondary Outcome Measures :
  1. treatment-related adverse events [ Time Frame: one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047186


Contacts
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Contact: Xiangning Fu, MD +8613607150390 fuxn2006@aliyun.com
Contact: Shu Peng, PhD +8618571716422 drpeng90@hotmail.com

Locations
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China, Hubei
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, China, 430030
Contact: Xiangning Fu, MD    0086-13607150390    Fuxn2006@aliyun.com   
Contact: Shu Peng, PhD    0086-18571716422    drpeng90@hotmail.com   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Tongji Hospital
ClinicalTrials.gov Identifier: NCT04047186    
Other Study ID Numbers: 2019CR107
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: According to regulation of institution, IPD can not be shared.

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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
Keywords provided by Tongji Hospital:
immunotherapy
Multiple Pulmonary Nodules
Lung Neoplasms
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents