Actively Recruiting
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
Led by Ruijin Hospital · Updated on 2024-09-23
56
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.
CONDITIONS
Official 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 the time of study entry
- Histologically confirmed unresectable stage III non-small-cell lung cancer
- Provided fully informed written consent
- Unfit for concurrent chemoradiotherapy due to one of the following: ECOG performance status 2, age 70 or older, or ECOG 1 with Charlson Comorbidity Index of 1 or higher
- Adequate bone marrow, liver, and kidney function
- Life expectancy of at least 3 months
- At least one measurable thoracic lesion suitable for radiation as per RECIST 1.1
- Histologic or cytologic confirmation of small cell lung cancer
- Adequate lung function with FEV1 greater than 1 liter or more than 30% of predicted value and DLCO more than 30% of predicted value
You will not qualify if you...
- Previous chemotherapy, immunotherapy, or radiotherapy for NSCLC
- Major surgery within the last 28 days
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis, or HIV
- Uncontrolled illness occurring at the time of enrollment
- Presence of other active cancers
- Leptomeningeal carcinomatosis
- Use of immunosuppressive medications
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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