This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer.
This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively collected disease history, treatment history, demographic data, baseline data during treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with monotherapy. The subjects did not voluntarily withdraw from the test or the researchers believed that the subjects were not suitable for further test. Each subject will be treated until the disease progresses or the toxic and side effects caused by the drugs are intolerable, and the follow-up treatment plan, treatment status and survival data of the patients still need to be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2
Objective response rate
Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
Time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Disease control rate
Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
Time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Progression-free survival time
The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
Time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Overall survival time
The time between the patient's date of first treatment and death from any cause.
Time frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
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