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
Overview
- Phase
- Phase 1
- Intervention
- Tirelizumab；Chemotherapy monotherapy
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 31
- Primary Endpoint
- Objective response rate
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Tirelizumab in combination with chemotherapy monotherapy
This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy.
Intervention: Tirelizumab；Chemotherapy monotherapy
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 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 Outcomes
- Disease control rate(Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.)
- Progression-free survival time(Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.)
- Overall survival time(Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.)