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

Xiangya Hospital of Central South University1 site in 1 country60 target enrollmentJuly 1, 2020

ConditionsNon-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage ⅢA Non-small Cell Lung Cancer Stage IIIB

Interventionsnivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5

Drugsnivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5

Overview

Phase: Phase 2
Intervention: nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5
Conditions: Non-small Cell Lung Cancer Stage II
Sponsor: Xiangya Hospital of Central South University
Enrollment: 60
Locations: 1
Primary Endpoint: Pathological complete response
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

December 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xiangya Hospital of Central South University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed previously untreated non-small cell lung cancer. Patients with stage II, 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;
•Patients with measurable or evaluable diseases (according to RECIST 1.1);
•Patients must have the ability to swallow oral drugs;
•Patients with adequate pulmonary function capable of tolerating the proposed lung resection (as determined by the surgeon);
•Signed and dated written informed consent must be provided by the patient prior to admission to the study.

Exclusion Criteria

•Subjects with known ALK translocations or EGFR mutations.
•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.

Arms & Interventions

Arm 1

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)

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

Outcomes

Primary Outcomes

Pathological complete response

Time Frame: Within 3 days after the operation

The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review.

Secondary Outcomes

Objective response rate(28 days after the completion of three cycles of neoadjuvant therapy and before the operation)
Major Pathologic Response(Within 3 days after the operation)
Disease free survival(1 year, 3 years and 5 years after the operation)
Recurrence rate(1 year, 3 years and 5 years after the operation)
Overall survival(1 year, 3 years and 5 years after the operation)
Adverse effects(Treatment-related adverse events were assessed between the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment.)
Surgical complications (intra-operative and peri-operative)(90 days after the first medication or 30 days after the operation, whichever is later)
R0 surgical events(28 days after the completion of three cycles of neoadjuvant therapy)
Clinical TNM downstaging(28 days after the completion of three cycles of neoadjuvant therapy and before the operation)