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Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial
Led by Ruijin Hospital · Updated on 2024-09-23
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for elderly and/or frail patients with unresectable stage III non-small-cell lung cancer (NSCLC) who are not eligible for standard concurrent chemoradiotherapy due to poor health, older age, or other medical conditions. The study aims to evaluate the effectiveness and side effects of a sequential combination of chemotherapy and immunotherapy followed by thoracic radiotherapy, and to determine the best radiotherapy dose for this group of patients. This approach addresses the need for safer treatment options for those who cannot tolerate the usual care involving concurrent chemotherapy and radiotherapy. Participants will receive sequential chemo-immunotherapy and then be randomly assigned to one of two groups: one receiving a standard dose of thoracic radiotherapy (60 Gy over 30 fractions) and the other receiving a reduced dose of thoracic radiotherapy (50 Gy over 25 fractions). Both groups will continue with maintenance therapy using anti-PD-1 or anti-PD-L1 drugs for at least six months following radiotherapy. This design allows comparison of the two radiotherapy doses combined with immunotherapy to find the optimal treatment balance for these patients. During the study, patients will be monitored for disease progression and treatment side effects. The main outcome measured is progression-free survival at 12 months after the last patient joins the trial. Researchers will also track overall survival at one and five years, as well as treatment-related adverse events within one year. Participants will undergo regular assessments including imaging to evaluate tumor response, and tests to assess lung, liver, kidney, and bone marrow function. The study is planned to continue until 2026, with ongoing safety and effectiveness monitoring throughout.
CONDITIONS
Brief Title
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at study entry
- Diagnosed with unresectable stage III non-small-cell lung cancer
- Provided fully informed written consent
- Considered unfit for concurrent chemoradiotherapy due to either ECOG 2, age 70 or older, or ECOG 1 with Charlson Comorbidity Index of 1 or more
- Adequate bone marrow, liver, and kidney function
- Life expectancy of at least 3 months
- At least one measurable thoracic lesion suitable for radiotherapy
- Confirmed diagnosis of small cell lung cancer by histology or cytology
- Adequate lung function with FEV1 greater than 1 liter or more than 30% predicted and DLCO more than 30% predicted
You will not qualify if you...
- Previous chemotherapy, immunotherapy, or radiotherapy for non-small-cell lung cancer
- Major surgery within the last 28 days
- History of organ transplant, autoimmune disease, immunodeficiency, hepatitis, or HIV
- Uncontrolled other illnesses
- Having another active cancer
- Presence of leptomeningeal carcinomatosis
- Taking immunosuppressive medication
- Pregnant or breastfeeding
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 - Approximately 6 months or more
Participants receive sequential chemo-immunotherapy followed by thoracic radiotherapy and continue with anti-PD-1/PD-L1 maintenance therapy.
Multiple visits for chemotherapy, radiotherapy, and maintenance therapy
Duration - Up to 5 years after treatment completion
Participants are monitored for progression-free survival, overall survival, and treatment-related adverse events.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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