advanced metastatic non-small cell lunG cancer and with symptoms of deficiency of lung and renal (cough, asthma, back pain)
Conditions
Interventions
Bailing Jiaonang Group:Drug interventions
Bailing Jiaonang Placebo Group:Drug interventions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be met at screening to be included in the trial: (1) Age =18 and =75 years with an expected survival of =3 months; (2) Patients with stage IV non-small cell lung cancer not previously treated with systemic therapy and confirmed by histology/cytology; (3) Patients with symptoms related to both lung and kidney deficiency (cough, shortness of breath, low back pain); (4) Physical status score (PS) of 0-2; (5) Have at least one measurable lesion according to RECIST 1.1 criteria; (6) Any PD-L1 status, first-line application of the protocol-specified PD-1 combination chemotherapy regimen (squamous carcinoma: paclitaxel/albumin paclitaxel + platinum in combination with pabrolizumab or tirilizumab, paclitaxel + carboplatin in combination with karelizumab or pegfilgrastimab, gemcitabine + platinum in combination with cindolizumab, albumin paclitaxel + platinum in combination with srulizumab; non-squamous carcinoma: pemetrexed + platinum in combination with pabrolizumab (Pembrolizumab or Carrelizumab or Sindelizumab or Tirilizumab or Trepilizumab); (7)Volunteer to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients will not be allowed to enter this trial if they meet any of the following criteria (1) Pulmonary radiation therapy, radioactive iodine, thyroidectomy, antithyroid therapy within the last 3 months, combined with severe infection, active tuberculosis; (2) History of non-infectious pneumonia requiring glucocorticoid use; (3) Active autoimmune disease or undergoing systemic immunosuppressive therapy; (4) Symptomatic central nervous system metastases, or active hepatitis B or C virus infection; (5) Prior treatment with immune checkpoint inhibitors; (6) Patients positive for EGFR-sensitive mutations/ALK fusions/ROS1 fusions; (7) Inability to swallow study drug; (8) Active malabsorption disorder or history of gastrointestinal resection; (9) Participation in other clinical trials in the last 3 months; (10) History of allergy to components of the test drug; (11) Pregnant or lactating women and those who are unable to use strict contraception during the trial; (12) Patients treated with Chinese herbal medicines with antitumor effects, and other cordyceps preparations within 15 days prior to the use of the study drug, and during the study period; (13)Other conditions deemed by the investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2-3 grades irAEs (checkpoint inhibitor-Related pneumonitis, hyperthyroidism/ hypothyroidism, renal toxicity) within 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to onset and median time to regression of 2-3 grades irAEs during the study period;Changes in irAE ratings of patients in both groups during the study period;Changes in patients' ePRO assessment results: patients' psychological scores (Self-Depression Scale SDS and Self-Anxiety Scale SAS), quality of life assessment (QLQ-C30 scale);Efficacy analysis of antitumor therapy: ORR, PFS and 6-month PFS rate, 12-month PFS rate.; | — |
Countries
China
Contacts
Public ContactChu Qian
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Outcome results
None listed