Clinical trial · Interventional
Phase II Trial of SFRT Plus Chemo-immunotherapy for LA-NSCLC With Suboptimal Neoadjuvant Response
Spatially Fractionated Radiotherapy Combined With Chemo-immunotherapy for Locally Advanced Non-Small Cell Lung Cancer With Suboptimal Response to Initial Neoadjuvant Therapy: A Single-Arm, Open-Label, Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Neoadjuvant Chemoimmunotherapy | — | UNRESOLVED | — |
| Thoracic Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lattice radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- 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
- interventionNames
- Radiation: lattice radiation therapy
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- From enrollment up to 12 months after the last subject completes combination therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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