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Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Potential/Resectable NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699721
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Study Description
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Brief Summary:
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Stage III Drug: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Potential/Resectable Non-small Cell Lung Cancer
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5
    3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)
    Other Name: Bifidobacterium trifidum live powder (BiFico, SINE)

Outcome Measures
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Primary Outcome Measures :
  1. adverse effects [ Time Frame: 90 days after the first medication or 30 days after the operation, whichever is later ]
    safety

  2. Surgical complications (intra-operative and peri-operative) [ Time Frame: 90 days after the first medication or 30 days after the operation, whichever is later ]
    safety

  3. non-R0 surgical events [ Time Frame: 28 days after the completion of three cycles of neoadjuvant therapy ]
    effectiveness


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 12 weeks (±7 days) after the operation, then every 12 weeks for 2 years ]
    effectiveness

  2. Major Pathologic Response [ Time Frame: 12 weeks (±7 days) after the operation, then every 12 weeks for 2 years ]
    effectiveness

  3. Disease free survival [ Time Frame: 1 year and 2 years after the operation ]
    effectiveness

  4. Recurrence rate [ Time Frame: 1 year and 2 years after the operation ]
    effectiveness

  5. Overall survival [ Time Frame: up to 2 years ]
    Time from beginning of treatment to death or 2 year, whichever comes first


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed previously untreated non-small cell lung cancer. Patients with stage IIIA and potentially resectable stage IIIB (T3N2) disease (according to AJCC 8th edition) are eligible ;
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
  • 18 years ≤ Age ≤ 80 years. Signed and dated written informed consent must be provided by the patient prior to admission to the study;
  • Patients with appropriate treatment compliance and could be followed-up correctly;
  • Measurable or evaluable diseases (according to RECIST 1.1);
  • Patients must have the ability to swallow oral drugs.

Exclusion Criteria:

  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
  • Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included. If you have any questions, please contact the trial team;
  • Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
  • Patients who are inability to follow the procedures required in the protocol due to any medical, mental or psychological conditions;
  • Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody or any other antibodies or drugs that target T cell costimulation or immune checkpoint pathways;
  • Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection;
  • Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome;
  • Patients with a history of allergy to study drugs or ingredients.
Contacts and Locations
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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): NCT04699721


Contacts
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Contact: Yang Gao, Doctor +86 13973171096 drgaoyang@sina.cn
Contact: Zhaoqian Liu, Doctor +86 13787797720 zqliu@csu.edu.cn

Locations
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China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Yang Gao, Doctor    +86 13973171096    drgaoyang@sina.cn   
Contact: Zhaoqian Liu, Doctor    +86 13787797720    zqliu@csu.edu.cn   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Study Director: Yang Gao, Doctor Xiangya Hospital of Central South University
More Information
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT04699721    
Other Study ID Numbers: 202007093
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: IPD will be shared when the clinical trail is finished

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
 Carboplatin
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors