Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single-arm, Single-center, Exploratory Clinical Study of Tirelizumab Combined With Chemotherapy in First-line Treatment of ECOG PS 2 Points in Relapsed/Metastatic Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tirelizumab；Chemotherapy monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission. The age range is between 18 and 85. Predicted survival ≥12 weeks. Exclusion Criteria: Patients with other malignant tumors. Positive tests for EGFR mutation and ALK fusion gene have been confirmed. Partial comorbidity. other.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirelizumab in combination with chemotherapy monotherapy<br>This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy. | Drug: Tirelizumab；Chemotherapy monotherapy<br>* Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria. | 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. | 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. | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. |