Clinical trial NCT04699721: Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC
Official title: Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage ⅢA
Non-small Cell Lung Cancer Stage IIIB
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Pathological complete response
timeFrame: Within 3 days after the operation
Secondary outcomes:
measure: Objective response rate
timeFrame: 28 days after the completion of three cycles of neoadjuvant therapy and before the operation
measure: Major Pathologic Response
timeFrame: Within 3 days after the operation
measure: Disease free survival
timeFrame: 1 year, 3 years and 5 years after the operation
measure: Recurrence rate
timeFrame: 1 year, 3 years and 5 years after the operation
measure: Overall survival
timeFrame: 1 year, 3 years and 5 years after the operation
measure: Adverse effects
timeFrame: Treatment-related adverse events were assessed between the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment.
measure: Surgical complications (intra-operative and peri-operative)
timeFrame: 90 days after the first medication or 30 days after the operation, whichever is later
measure: R0 surgical events
timeFrame: 28 days after the completion of three cycles of neoadjuvant therapy
measure: Clinical TNM downstaging
timeFrame: 28 days after the completion of three cycles of neoadjuvant therapy and before the operation
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yang Gao, Doctor
role: STUDY_DIRECTOR
References: