Actively Recruiting
Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
Led by Hubei Cancer Hospital · Updated on 2024-03-15
49
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, at the same time, it is also the age group with the highest lung cancer mortality, but there is little evidence for treatment of elderly lung cancer patients. In this study, the investigators set the definition of the elderly to 65 years and older. The progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy were higher than those of chemotherapy alone, which established the dominant position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly patients benefit from immunotherapy. It is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can not significantly prolong OS, and can not improve the overall health status of patients. Based on the results of this study, single drug chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era of immunotherapy, it is not clear whether single-drug chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.
CONDITIONS
Official Title
Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 or older with performance status 0 to 2
- Diagnosis of metastatic non-small cell lung cancer confirmed by histology or cytology
- No mutations or fusions in common driving genes EGFR, ALK, or ROS1 (adenocarcinoma requires genetic testing)
- Positive PD-L1 expression with tumor proportion score of 1% or higher
- First-line treatment with stable brain or bone metastases or stable symptoms after local treatment
- Available enhanced CT images of chest and supraclavicular area before treatment and measurable tumor lesions
- Estimated survival time of at least 6 months
- Laboratory results within 2 weeks before treatment showing hemoglobin ≥110 g/L, leukocytes ≥4x10^9/L, platelets ≥100x10^9/L, and liver/kidney function within 1.25 times upper normal limit
- Informed consent signed and voluntary participation
You will not qualify if you...
- Presence of mutations or fusions in EGFR, ALK, or ROS1 genes
- Previous systemic treatment for lung cancer
- History of other malignant tumors except stage I non-melanotic skin cancer or cervical carcinoma in situ
- Current involvement in other drug trials
- Positive HIV infection receiving antiviral therapy
- Active pulmonary tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
G
Guang Han
CONTACT
L
Lulu Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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