A Phase 2 interventional study of lattice radiation therapy in Locally Advanced Non-small Cell Lung Cancer (NSCLC), Thoracic Radiotherapy and Immune Checkpoint Inhibitors, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
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.
Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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Exclusion Criteria:
Eligible patients with unresectable stage III LA-NSCLC who achieved suboptimal tumor response after prior neoadjuvant chemoimmunotherapy in this Phase II trial will receive thoracic lattice radiation therapy using a medical linear accelerator. Within the gross tumor volume (GTV) of primary lung lesions and metastatic regional lymph nodes, spherical high-dose LRT sub-targets will be delineated with fixed diameter and inter-target spacing standards. The LRT sub-targets must be contoured fully within the GTV, spare vital intrathoracic vessels, maintain a minimum safety margin from the outer GTV border, and account for a regulated volume percentage of the whole GTV. For thoracic tumor lesions, the D95 coverage of total GTV and individual LRT high-dose targets will follow defined per-fraction dose limits, while all efforts will be made to lower single-fraction radiation burden to lung, heart and esophagus organs at risk. After finishing the full course of lattice radiotherapy, standardized
Radiation: lattice radiation therapy
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.
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
Plan to share: No
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Tianjin Medical University Cancer Institute and Hospital