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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed unresectable stage III locally advanced non-small cell lung cancer (LA-NSCLC).
2. Received at least 2 cycles of standard neoadjuvant chemoimmunotherapy, with suboptimal tumor response verified by post-induction radiological evaluation.
3. Age ≥ 18 years old.
4. ECOG performance status of 0 or 1.
5. Adequate hematologic, hepatic and renal function to complete radiotherapy and consolidation systemic therapy.
6. Voluntarily sign written informed consent and be capable of following study-related procedures.
Exclusion Criteria:
1. Prior thoracic radiotherapy history.
2. Active uncontrolled autoimmune disorders or persistent severe immune-related adverse events.
3. Untreated symptomatic brain metastases.
4. Severe irreversible cardiac, pulmonary, liver or renal dysfunction that cannot tolerate combined radiotherapy and immunotherapy.
5. Pregnant or breastfeeding women.
6. Concurrent or previous other malignant tumors within 5 years, except cured basal cell skin cancer and cervical carcinoma in situ.
7. Any absolute contraindication to lattice radiation therapy or immune checkpoint inhibitor.
Primary outcome measure(s)
Objective response rate — From enrollment up to 12 months after the last subject completes combination therapy 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 — From enrollment to 12 months after the last subject completes all study combination therapy The proportion of patients achieving pathological complete response (pCR), defined as absence of viable residual tumor cells in post-treatment surgical resection specimens.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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