NCT07670715Not yet recruitingPhase 2
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 · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07670715
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thoracic radiotherapy history.
- Any absolute contraindication to lattice radiation therapy or immune checkpoint inhibitor.
Other illness
- Active uncontrolled autoimmune disorders or persistent severe immune-related adverse events.
- Severe irreversible cardiac, pulmonary, liver or renal dysfunction that cannot tolerate combined radiotherapy and immunotherapy.
- Concurrent or previous other malignant tumors within 5 years, except cured basal cell skin cancer and cervical carcinoma in situ.
Other
- Untreated symptomatic brain metastases.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
- Adequate hematologic, hepatic and renal function to complete radiotherapy and consolidation systemic therapy.
- Voluntarily sign written informed consent and be capable of following study-related procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.