Non-small Cell Lung Cancer
Conditions
Brief summary
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
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.
Interventions
DRUGTirelizumab；Chemotherapy monotherapy
Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. The age range is between 18 and 85. 3. Predicted survival ≥12 weeks.
Exclusion criteria
1. Patients with other malignant tumors. 2. Positive tests for EGFR mutation and ALK fusion gene have been confirmed. 3. Partial comorbidity. 4. other.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. | Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. | Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria. |
| Progression-free survival time | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. | The time between the patient's first treatment date and any recorded tumor progression or death from any cause. |
| Overall survival time | Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded. | The time between the patient's date of first treatment and death from any cause. |
Contacts
Primary ContactJingqi Chen, MD
Outcome results
None listed