Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC
- Sponsor
- Xiangya Hospital of Central South University
- Study ID
- NCT04699721
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Non-small Cell Lung Cancer Stage II
- Non-small Cell Lung Cancer Stage IIIB
- Non-small Cell Lung Cancer Stage ⅢA
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 — DRUG3 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)
Study Details
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.
Key Dates
- Start date
- Jul 1, 2020
- Status verified
- Jul 2024
- Primary completion
- Sep 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 13 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)
Primary Outcome Measure
Pathological complete response [ Time Frame: Within 3 days after the operation ]
Related Studies
- Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)PHASE2 · Recruiting · Stanford University · Stanford, California
- A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung DiseasePHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
- A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung CancerPHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Ann Arbor, Michigan
- Nebulized AER101 in Pre-op NSCLCEARLY_PHASE1 · Not Yet Recruiting · University of Oklahoma · Oklahoma City, Oklahoma