Lung cancer
Conditions
Interventions
Experience group:Fecal bacteria transplantation, Pembrolizumab, Pemetrexed and Carboplatin.
Control group:Placebo, Pembrolizumab, Pemetrexed and Carboplatin
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent. The informed consent must be signed before proceeding with any program related procedures. Subjects must be willing and able to comply with scheduled visits, treatment regiments, laboratory tests, and other requirements of the study. 2. The age at the time of signing the informed consent is >= 18 years old and = 3 months. 5. Metastatic (stage IV) non-squamous, non-small cell lung cancer (NSCLC) with histological or cytological confirmation that it is inoperable and cannot be treated with radical concurrent chemoradiotherapy, according to TNM staging in the 8th edition of the international association for lung cancer research and the American joint committee on the classification of cancer. 6. Subjects have not received systemic chemotherapy for advanced or metastatic NSCLC before. For patients who have received adjuvant chemotherapy, neoadjuvant chemotherapy or radical radiotherapy and chemotherapy for advanced diseases for the purpose of cure, if the disease progress occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study. 7. According to the recist1.1 standard, there is at least one measurable tumor focus; the previously received radiotherapy focus can not be selected as the target focus; during the baseline screening period, CT or MRI was used to check whether the long diameter of the focus >= 10 mm (the short diameter of the lymph node focus >= 15 mm), and according to the RECIST v1.1 guide, the focus is suitable for repeated and accurate measurement. 8. It is necessary to provide tumor tissue samples at or after the diagnosis of advanced or metastatic tumors, about 10 pathological sections (preferably newly obtained tumor tissue samples) archived or freshly obtained within 6 months before the first application. The samples of fine-needle aspiration biopsy, cell smear of pleural effusion drainage and centrifugation, or drilling biopsy are not enough for biomarker detection. Osteopathy without soft tissue components or samples of decalcified bone tumors is also unacceptable. Tumor lesions for fresh biopsies should not be targeted for RECIST 1.1 unless no other lesions are suitable for biopsies. If the target lesion of RECIST 1.1 is used for biopsy, it must be biopsied outside the screening stage. 9. It must be able to provide reports that both EGFR and alk are wild-type through tissue-based testing. For non squamous NSCLC patients not confirmed as wild-type EGFR and wild-type ALK, tumor samples (archived or fresh, primary or metastatic) need to be collected for evaluation of EGFR and ALK examination (in local laboratory or central laboratory) before enrollment. If tumor tissue is not archived, fresh biopsy samples must be collected at baseline. 10. The results of laboratory examination during the screening period indicated that the subjects had good organ function (no blood components and cell growth factor were allowed to support the treatment within the first two weeks of randomization): (1) Hematology: I. neutrophil absolute value NEC >= 1.5 x 10^9/ L; II. Platelet count >= 100 x 10^9/L; III. hemoglobin >= 9.0g/dl. (2) Kidney: I. calculated value of creatinine clearance rate (CrCl) >= 50 ml / min, CrCl (Cockcroft DW, 1976) CrCl (ml / min) = {(140 - age) x weight (kg
Exclusion criteria
Exclusion criteria: 1. NSCLC diagnosed with EGFR sensitive mutation and ALK gene translocation. 2. Non-small cell lung cancer subjects of other histopathological types, including squamous mixed cancer subjects, mixed cancer subjects with small cell lung cancer and neuroendocrine cancer subjects. 3. Previous treatment with EGFR or ALK antagonists. 4. Previously participated in the study of experimental drugs or received research treatment or used experimental instruments within 4 weeks before the first administration. 5. To be enrolled in another clinical study at the same time, unless it is an observation, non intervention clinical study or follow-up period of intervention study (defined as the first time of administration is more than 4 weeks from the last time of the previous clinical study or more than 5 half lives of the study drug). 6. Receive the last radiotherapy or anti-tumor treatment within 3 weeks before the first administration, including chemotherapy, targeted treatment, immunotherapy, Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin) or tumor embolization, etc 7. Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug treatment for T cell co stimulation or checkpoint pathway, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.). 8. There were other active malignant tumors within 5 years before admission. Locally curable cancers (which appear to be cured) are excluded, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 9. Patients with active, known or suspected autoimmune diseases, or a history of autoimmune diseases, except for vitiligo, alopecia, Graves' disease, psoriasis or eczema, hypothyroidism (caused by autoimmune thyroiditis) requiring only a stable dose of hormone replacement therapy, and pancreas requiring only a stable dose of hormone replacement therapy in the past 2 years Type I diabetes, or childhood asthma, which has been completely relieved by islandin replacement therapy, does not recur in adults without any intervention, or the disease does not recur without external triggers. 10. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). 11. Subjects requiring systemic treatment with corticosteroids (> 10 mg / day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to the first administration. The following exceptions: a) if there is no active autoimmune disease, it is allowed to use inhaled, ophthalmic or local steroids and adrenocortical hormone with a dose not exceeding 10 mg / day of prednisone. b) The physiological dose of systemic glucocorticoids does not exceed 10 mg / day of prednisone or the equivalent dose of other glucocorticoids. c) Glucocorticoid as a preventive drug for hypersensitivity (e.g. before CT). 12. Known history of primary immunodeficiency virus infection. 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. Large surgical procedures (defined by the investigator, such as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first administration. Note: it is acceptable to replace the intravenous drip. There was a major surgical planner within 30 days of the first administration (at the discretion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ???;Progression free survival;Fecal flora analysis; | — |
Countries
China
Contacts
Public ContactXin Wang
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed