Actively Recruiting
Prospective, Single-arm Phase II Study of Single-drug Chemotherapy Plus Immunotherapy in Elderly Patients with Metastatic Non-small Cell Lung Cancer
Led by Hubei Cancer Hospital · Updated on 2024-03-15
49
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer is the leading cause of illness and death among men worldwide, with elderly patients aged 65 and older representing a growing portion of those affected. This research focuses on elderly patients with metastatic non-small cell lung cancer (NSCLC) to evaluate treatment options, as this age group has limited evidence guiding their care. The study aims to clarify whether single-drug chemotherapy combined with immunotherapy offers benefits similar to dual-drug chemotherapy with immunotherapy while reducing side effects. Participants receive single-drug chemotherapy plus immunotherapy tailored to the type of lung cancer. For squamous cell carcinoma, chemotherapy options include gemcitabine, paclitaxel, or vinorelbine combined with immunotherapy drugs such as Pembrolizumab, Penpulimab, Camrelizumab, Tislelizumab, Sintilimab, or sulgarizumab. For non-squamous NSCLC, paclitaxel or pemetrexed plus immunotherapy are used. This is a phase II clinical trial with one treatment group. During the study, researchers monitor participants for progression-free survival and objective response rate within 6 to 12 months, as well as overall survival and disease control up to 18 months. Assessments include imaging with enhanced CT scans and laboratory tests for blood counts and organ function. The study measures treatment efficacy, safety, and quality of life in elderly patients receiving first-line therapy for metastatic NSCLC.
CONDITIONS
Brief 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 years or older with a performance status (PS) score of 0 to 2
- Confirmed metastatic non-small cell lung cancer (NSCLC) by histology or cytology
- No mutations or fusions in common genes such as EGFR, ALK, or ROS1 (adenocarcinoma requires genetic testing)
- Positive PD-L1 expression with tumor proportion score (TPS) of 1% or higher
- First-line treatment status with stable brain or bone metastases or stable symptoms after local treatment
- Available enhanced CT scans of chest and supraclavicular area with measurable tumor lesions
- Estimated survival time of at least 6 months
- Laboratory tests within 2 weeks before treatment showing hemoglobin ≥110 g/L, leukocytes ≥4x10^9/L, platelets ≥100x10^9/L, and liver and kidney function within 1.25 times upper normal limits
- Ability to understand study and provide informed consent
You will not qualify if you...
- Presence of mutations or fusions in EGFR, ALK, or ROS1 genes
- Prior systemic treatment for lung cancer
- History of other malignant tumors except stage I non-melanotic skin cancer or cervical carcinoma in situ
- Participation in another drug study
- Positive HIV status with ongoing antiviral therapy
- Active pulmonary tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive single-drug chemotherapy plus immunotherapy as their first-line treatment for metastatic non-small cell lung cancer.
Regular visits during treatment as scheduled by the trial team
Duration - Up to 6 months after treatment
Participants are monitored for overall survival and disease control after treatment ends.
Visits scheduled for outcome assessments
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
G
Guang Han
L
Lulu Shi
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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