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

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

Official Title
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Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Potential/Resectable Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer Stage III

Intervention / Treatment
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* Drug: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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) | Drug: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5<br>* 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)<br>* Other names: Bifidobacterium trifidum live powder (BiFico, SINE);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects | safety | 90 days after the first medication or 30 days after the operation, whichever is later | 
| Surgical complications (intra-operative and peri-operative) | safety | 90 days after the first medication or 30 days after the operation, whichever is later | 
| non-R0 surgical events | effectiveness | 28 days after the completion of three cycles of neoadjuvant therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | effectiveness | 12 weeks (±7 days) after the operation, then every 12 weeks for 2 years | 
| Major Pathologic Response | effectiveness | 12 weeks (±7 days) after the operation, then every 12 weeks for 2 years | 
| Disease free survival | effectiveness | 1 year and 2 years after the operation | 
| Recurrence rate | effectiveness | 1 year and 2 years after the operation | 
| Overall survival | Time from beginning of treatment to death or 2 year, whichever comes first | up to 2 years |