This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.
This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities. Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy followed by immunotherapy consolidation will be randomly divided into two groups (concurrent Tα1 treatment group and control group \[in which Tα1 will not be used\]), and the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be compared between these two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Participants were treated with definitive thoracic radiotherapy
All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
Completion rate of immunotherapy
Proportion of participants completing 12 months of consolidation of immutherapy
Time frame: Calculated from the start of treatment to one year after the last treatment completion
Overall survival
Time frame: 2 years
Progression-free survival
Time frame: one year
Incidence of ≥grade 2 pneumonia
Time frame: through study completion, an average of 1 year
Drop-out rate during the I/O consolidation
Time frame: One year
The absolute count of total lymphocyte in peripheral blood
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
Time frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ)
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
Time frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
The absolute count of peripheral blood lymphocyte subsets (including CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, and CD56+ NK cells, PD-1+CD8+ T cells, Tim3+ CD8+ T cells, CD62lowCD4+ T cells, PD-1+CD4+ T cells, and Tim3+CD4+ T cells
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
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Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1 would be administered according to the following three stages: 1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on d1 and d3 for each cycle. 2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously administered at 4.8mg biweekly. 3. Immunotherpay consolidation: Tα-1 will be administered concurrently with tislelizumab at 4.8mg (Q3W) for up to 12 months.
Time frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months