To hear about similar clinical trials, please enter your email below
Trial Title:
Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer
NCT ID:
NCT05965102
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tirelizumabï¼›Chemotherapy monotherapy
Description:
Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic
non-small cell lung cancer with ECOG PS score of 2
Arm group label:
Tirelizumab in combination with chemotherapy monotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965102
