Status:
ACTIVE_NOT_RECRUITING
Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage ⅢA
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04699721
Start Date
July 1 2020
End Date
December 1 2027
Last Update
November 22 2024
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008