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

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04699721
• Other study ID #: 202007093
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: December 2027

Study information

• Verified date: January 2023
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III

Intervention

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)

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse effects	safety	90 days after the first medication or 30 days after the operation, whichever is later
Primary	Surgical complications (intra-operative and peri-operative)	safety	90 days after the first medication or 30 days after the operation, whichever is later
Primary	non-R0 surgical events	effectiveness	28 days after the completion of three cycles of neoadjuvant therapy
Secondary	Objective response rate	effectiveness	12 weeks (±7 days) after the operation, then every 12 weeks for 2 years
Secondary	Major Pathologic Response	effectiveness	12 weeks (±7 days) after the operation, then every 12 weeks for 2 years
Secondary	Disease free survival	effectiveness	1 year and 2 years after the operation
Secondary	Recurrence rate	effectiveness	1 year and 2 years after the operation
Secondary	Overall survival	Time from beginning of treatment to death or 2 year, whichever comes first	up to 2 years