Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients

Launched by HUBEI CANCER HOSPITAL · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a combination of single-drug chemotherapy and immunotherapy is for elderly patients (65 years and older) who have advanced non-small cell lung cancer that has spread to other parts of the body. The researchers want to find out if this treatment works better than the traditional dual-drug chemotherapy combined with immunotherapy. They believe that many elderly patients could benefit from this approach, especially since there is limited research on how to treat lung cancer in older adults.

To be eligible for the trial, participants must be at least 65 years old and have a specific type of lung cancer confirmed by medical tests. They should not have certain gene mutations and must show positive results for a specific protein that helps the immune system fight cancer. Participants will receive treatment and be monitored for their health and response to the therapy. It’s important to note that individuals with other active cancers, certain infections like HIV, or those who have received prior treatments for lung cancer are not eligible to join this study. This trial is currently recruiting participants who meet the criteria and wish to contribute to advancing lung cancer treatment for older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Regardless of sex, age ≥ 65, PS 0-2.
• • 2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.
• • 3. 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).
• • 4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).
• • 5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).
• • 6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.
• • 7. The estimated survival time is not less than 6 months.
• • 8. 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.
• • 9. Informed understanding and voluntary participation in this study, and informed consent has been signed.
• Exclusion Criteria:
• • 1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).
• • 2. Have received systemic treatment before.
• • 3. 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.
• • 4. Other drugs are being tested.
• • 5. Patients with positive HIV and are receiving antiviral therapy .
• • 6. Active pulmonary tuberculosis.