To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.
Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Vinorelbine is administered orally at 60mg per square meter per week by body surface area before radiotherapy and continued to be administered at 30mg per square meter per week during radiotherapy until the end of radiotherapy. Within 6 weeks after the end of radiotherapy, there are no serious side effects, and immune checkpoint inhibitors monotherapy can be performed.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Overall survival
The time between the start of treatment and death from any cause in the one-arm trial
Time frame: 5 years
objective response rate
The ratio of complete response and partial response at 3 months after the end of radiotherapy
Time frame: 3 months
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