Randomized and placebo-controlled clinical Study of Bushen Tiaoyuan Tongluo Formula in Combination with PD-1 Inhibitor and Chemotherapy for Advanced Non-small Cell Lung Cancer

Phase 1

• Conditions: on-small Cell Lung Cancer

• Registration Number: ITMCTR2000003240
• Lead Sponsor: Shanghai Pulmonary Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Patients with stage IIIB / stage IV NSCLC diagnosed by pathology or cytology. 2) The selected patients are the first diagnosis and will be the first-line chemotherapy patients. 3) Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up. 4) Patients with CNS metastasis can be fully treated, and the neurological symptoms of the subjects can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to CNS treatment); 5) Patients do not use corticosteroids or receive prednisone (or equivalent) <= 10 mg / day at a stable or gradually decreasing dose; 6) Patients must have measurable lesions that are examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before randomization; 7) Age 18 and over, regardless of gender; 8) ECOG score: 0-1; 9) Expected survival time >= 12 weeks; 10) The function of important organs meets the following requirements (excluding any use within 14 days before the first medication. Blood components and cell growth factors): Absolute neutrophil count >= 1.5 x 10^9 / L; Platelet >= 100 x 10^9 / L; Hemoglobin >= 9g / dL; Serum albumin >= 3g / dL; Thyrotropin (TSH) <= ULN (if abnormal, FT3 and FT4 levels should be investigated at the same time, if FT3 and FT4 levels are normal, they can be included in the group); Bilirubin <= ULN; ALT and AST <= 1.5 times ULN; AKP <= 2.5 times ULN; Serum creatinine <= 1.5 times ULN or creatinine clearance >= 60mL / min. 11) Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive method (such as an IUD, contraceptive or condom) during the study treatment and within 3 months after the end of the study treatment period; Surgical sterilized female patients of childbearing age must have anegative serum or urine HCG test within 72 hours before study enrollment; and must be non-lactating; for males, surgical sterilization, or agree to be given during the trial and after the last administration Use appropriate methods for contraception within 3 months;

Exclusion Criteria

1) With cancerous meningitis;
2) Patients with active central nervous system (CNS) metastasis;
3) The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, body inflammation, vasculitis , Nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has been completely relieved in childhood, can be included without any intervention after adulthood; subjects with asthma requiring medical intervention with bronchodilators cannot be included);
4) Subjects are being treated with immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and within 2 weeks before enrollment Still in use;
5) Previously used anti-tumor vaccine or other anti-tumor drugs with immunostimulating effect;
6) Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-CTLA-4 antibody (including ipilimumab or specific action on T cell co-stimulation or checkpoint pathway Any other antibody or drug);
7) Subjects have congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (B
Liver reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);
8) Patients with active tuberculosis (TB) infection.
9) Past and present history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug
Patients with objective evidence related to pneumonia and severely impaired lung function;
10) EGFR mutation (regardless of mutation type) or ALK translocation.
11) Other patients with serious primary diseases such as heart, brain, kidney and hematopoietic system, mental illness; pregnant and lactating women; critically ill and poor compliance.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and severe adverse events (grades 3 and 4);Objective response rate;Cancer Fatigue Score;

Secondary Outcome Measures

Name	Time	Method
Disease progression-free survival;Peripheral blood immune cells;Life quality assessment;Overall survival;Intestinal flora and metabolomics;Evaluation of the curative effect of Chinese medicine symptoms;