Locally Advanced Non-small Cell Lung Cancer (NSCLC)Phase 2NCT07670715
Phase II Trial of SFRT Plus Chemo-immunotherapy for LA-NSCLC With Suboptimal Neoadjuvant Response
A Phase 2 study testing lattice radiation therapy in people with Locally Advanced Non-small Cell Lung Cancer (NSCLC) and Thoracic Radiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-small Cell Lung Cancer (NSCLC), Thoracic Radiotherapy, Immune Checkpoint Inhibitors
- What is being tested?
- lattice radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Pregnant or breastfeeding women.
- Concurrent or previous other malignant tumors within 5 years, except cured basal cell skin cancer and cervical carcinoma in situ.
- Any absolute contraindication to lattice radiation therapy or immune checkpoint inhibitor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ningbo Liu, +8615602036608, liuningbo@tjmuch.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Locally Advanced Non-small Cell Lung Cancer (NSCLC), Thoracic Radiotherapy, Immune Checkpoint Inhibitors, Neoadjuvant Chemoimmunotherapy
- Being tested
- lattice radiation therapy
- Keywords
- spatially fractionated radiotherapy, Locally Advanced NSCLC, Neoadjuvant Chemoimmunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lattice radiation therapyRadiation
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 group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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 Receives: Radiation: lattice radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to 12 months after the last subject completes all study combination therapy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through 30 days after completion of all study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670715
- Sponsor's protocol ID
- E20260711
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07670715
- Acronym / sponsor ID
- E20260711
- Conditions
- Locally Advanced Non-small Cell Lung Cancer (NSCLC), Thoracic Radiotherapy, Immune Checkpoint Inhibitors, Neoadjuvant Chemoimmunotherapy
- Keywords
- spatially fractionated radiotherapy, Locally Advanced NSCLC, Neoadjuvant Chemoimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: lattice radiation therapyEligible 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lattice radiation therapyEligible 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. | Radiation | experimental group |
Primary outcome
Objective response rate
Time frame: 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
Time frame: 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.
4 secondary outcomes
Major pathological response
Time frame: From enrollment up to 12 months after the last subject completes combination therapy
R0 resection rate
Time frame: From enrollment up to 12 months after the last subject completes combination therapy
Event-free survival
Time frame: From enrollment up to 24 months after the last subject completes study treatment
Incidence of treatment-related adverse events
Time frame: From enrollment through 30 days after completion of all study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lattice radiation therapy in people with Locally Advanced Non-small Cell Lung Cancer (NSCLC) and Thoracic Radiotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ningbo Liu, Doctor (+8615602036608, liuningbo@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From enrollment up to 12 months after the last subject completes combination therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.