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

Central South University

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage ⅢA

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04699721

202007093

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Arm 1

Experimental group

Description:

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)

Treatment:

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