Lattice radiation therapy (LRT) is a spatially fractionated thoracic radiotherapy technique that creates alternating high- and low-dose regions within primary lung tumors and metastatic lymph nodes to strengthen local tumor suppression and reduce radiation injury to normal thoracic organs. This study aims to evaluate the efficacy and safety of combining LRT with consolidation chemoimmunotherapy in unresectable stage III LA-NSCLC patients who show suboptimal tumor response to prior neoadjuvant chemoimmunotherapy, through a single-arm Phase II clinical trial. Patients will receive thoracic LRT delivered by a medical linear accelerator. High-dose spherical sub-targets will be contoured within the gross tumor volume of primary lung lesions and regional nodal metastases under standardized dose constraints to spare the lung, heart and esophagus. All enrolled subjects will receive sequential consolidation chemoimmunotherapy administered within one week after finishing LRT. Tumor response, treatment-related adverse events, local tumor control and long-term survival outcomes will be prospectively tracked throughout treatment and long-term follow-up.
This open-label, single-arm Phase II clinical trial investigates the combination of lattice radiation therapy (LRT) and subsequent consolidation chemoimmunotherapy for patients with unresectable stage III locally advanced non-small cell lung cancer who only achieved limited tumor regression after standard neoadjuvant chemoimmunotherapy induction. LRT, a spatially fractionated radiotherapy technique, generates interleaved high- and low-dose zones inside tumor tissue to enhance local anti-tumor activity while minimizing radiation toxicity to surrounding healthy chest organs. Eligible participants will complete standardized thoracic LRT targeting primary lesions and involved lymph nodes following institutional contouring rules and dose restrictions. Consolidation chemoimmunotherapy will be initiated shortly after the end of radiotherapy. The study will continuously monitor all treatment-related and immune-related adverse events, evaluate therapeutic efficacy via regular imaging scans, and collect long-term survival data. Trial results will provide clinical evidence about the clinical value and safety profile of LRT plus consolidation chemoimmunotherapy for this high-risk LA-NSCLC subgroup with insufficient response to prior neoadjuvant systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Eligible stage III unresectable LA-NSCLC patients with suboptimal neoadjuvant response receive thoracic lattice radiotherapy via linear accelerator. Spherical high-dose LRT sub-targets are contoured inside primary and nodal GTV, avoiding blood vessels with 1cm margin and 1%-10% volume ratio of GTV. Standard fractional dose constraints for GTV and LRT targets are followed, with minimal radiation to heart, lung and esophagus. Brain and bone metastases get separate palliative radiotherapy, not included in thoracic LRT plan. Consolidation chemoimmunotherapy will be initiated within one week after radiotherapy completion.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Objective response rate
Objective response rate (ORR) assessed by RECIST version 1.1, calculated as the proportion of patients achieving complete response (CR) or partial response (PR) after combination therapy. Tumor lesions will be evaluated with contrast-enhanced CT scans of chest, abdomen and pelvis.
Time frame: From enrollment up to 12 months after the last subject completes combination therapy
Pathological complete response
The proportion of patients achieving pathological complete response (pCR), defined as absence of viable residual tumor cells in post-treatment surgical resection specimens.
Time frame: From enrollment to 12 months after the last subject completes all study combination therapy
Major pathological response
The proportion of patients achieving major pathological response (MPR), defined as ≤10% viable residual tumor cells in post-treatment surgical resection samples.
Time frame: From enrollment up to 12 months after the last subject completes combination therapy
R0 resection rate
The proportion of patients who achieve complete R0 surgical resection without microscopic residual tumor margin after the assigned combination therapy.
Time frame: From enrollment up to 12 months after the last subject completes combination therapy
Event-free survival
The time interval from participant enrollment to the first documented disease event, including local recurrence, distant metastasis, disease progression, or death from any cause.
Time frame: From enrollment up to 24 months after the last subject completes study treatment
Incidence of treatment-related adverse events
The frequency, classification and maximum severity of all treatment-related adverse events assessed in accordance with CTCAE Version 5.0.
Time frame: From enrollment through 30 days after completion of all study treatment
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