Status:
RECRUITING
Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
Lead Sponsor:
Hubei Cancer Hospital
Conditions:
Elderly Patients
Metastatic Lung Cancer
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The proportion of elderly lung cancer patients in the global lung cancer population is steadily increasing, a...
Detailed Description
Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The age range in which lung cancer is most commonly diagnosed is 65-74 years old. The proportion of elderly l...
Eligibility Criteria
Inclusion
- Regardless of sex, age ≥ 65, PS 0-2.
- metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.
- No mutation or fusion of common driving genes, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).
- (adenocarcinoma requires genetic testing).
- Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).
- First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).
- Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.
- The estimated survival time is not less than 6 months.
- The clinical laboratory criteria within 2 weeks before treatment are as follows: hemoglobin ≥ 110g / L, leukocytes ≥ 4x109 / L, platelet ≥ 100x109 / L, liver and kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit of the normal value.
- Informed understanding and voluntary participation in this study, and informed consent has been signed.
Exclusion
- Mutation or fusion of common driving genes (EGFR,ALK or ROS1).
- Have received systemic treatment before.
- Previous suffering from other malignant tumors (except stage I non-melanotic skin cancer or cervical carcinoma in situ) or other malignant tumors at the same time.
- Other drugs are being tested.
- Patients with positive HIV and are receiving antiviral therapy .
- Active pulmonary tuberculosis.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06032052
Start Date
February 1 2024
End Date
September 1 2027
Last Update
March 15 2024
Active Locations (1)
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1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079