FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChangzhou No.2 People's Hospital

About this trial

This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with standard first-line therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients.

Eligibility criteria

Qualifiers

The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;

Age 18-80 years old (when signing the informed consent form);

Patients with histologically or cytologically proven locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC who are inoperable and unable to receive radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, 8th Edition TNM Classification of Lung cancer;

Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;

Disqualifiers

Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;

Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;

Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;

Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;

Trial design

Treatments tested in this trial

  • Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy

Treatment groups

62 Participants
are divided into 1 treatment group