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.
Histologically confirmed unresectable stage III locally advanced non-small cell lung cancer (LA-NSCLC).
Received at least 2 cycles of standard neoadjuvant chemoimmunotherapy, with suboptimal tumor response verified by post-induction radiological evaluation.
Age ≥ 18 years old.
ECOG performance status of 0 or 1.
Prior thoracic radiotherapy history.
Active uncontrolled autoimmune disorders or persistent severe immune-related adverse events.
Untreated symptomatic brain metastases.
Severe irreversible cardiac, pulmonary, liver or renal dysfunction that cannot tolerate combined radiotherapy and immunotherapy.
Single group
lattice radiation therapy
RadiationEligible 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.
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.
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.
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.
R0 resection rate
The proportion of patients who achieve complete R0 surgical resection without microscopic residual tumor margin after the assigned 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.
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.
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