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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

Tracking Information
First Submitted Date  ICMJE August 4, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
pathological response rate [ Time Frame: one month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
treatment-related adverse events [ Time Frame: one month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
Official Title  ICMJE Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Pulmonary Nodules
Intervention  ICMJE Drug: Nivolumab Injection
Nivolumab 3mg/kg on day-28 and day-14 prior to planned surgical resection
Study Arms  ICMJE Experimental: neoadjuvant PD-1 group
receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor
Intervention: Drug: Nivolumab Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiangning Fu, MD +8613607150390 fuxn2006@aliyun.com
Contact: Shu Peng, PhD +8618571716422 drpeng90@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04047186
Other Study ID Numbers  ICMJE 2019CR107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: According to regulation of institution, IPD can not be shared.
Responsible Party Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP