Locally-Advanced Non-Small Cell Lung CancerPhase 1NCT07523464
Centrally Confined 8Gy/1f to Tumor Core Followed by Concurrent Chemoradiotherapy for Unresectable Stage III NSCLC
A Phase 1 study testing Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in people with Locally-Advanced Non-Small Cell Lung Cancer and Radiotherapy, run by Anhui Provincial Hospital.
Trial summary
This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally-Advanced Non-Small Cell Lung Cancer, Radiotherapy
- What is being tested?
- Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years;
- Histologically or cytologically confirmed NSCLC;
- Unresectable stage III disease according to the AJCC 8th edition;
- Negative for driver gene alterations;
- Considered suitable for definitive cCRT by MDT discussion or investigator judgment;
- ECOG performance status 0-1;
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- Presence of a clearly delineable pulmonary primary lesion allowing centrally confined priming treatment planning;
- Adequate major organ function as required by the study;
- Willingness to participate and provision of written informed consent.
Who cannot join
- Presence of distant metastasis;
- Positive driver gene alterations;
- Prior definitive thoracic radiotherapy or prior systemic antitumor treatment for the current disease;
- Active autoimmune disease or need for long-term systemic immunosuppressive therapy;
- Active interstitial lung disease, prior severe radiation pneumonitis, or immune-related pneumonitis;
- Special primary tumor location such that safety constraints for centrally confined priming radiotherapy cannot be met;
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- Primary lesion immediately adjacent to the main bronchus, carina, major vessels, or esophagus, such that the investigator judges the lead-in intervention to be excessively risky;
- Pregnancy or lactation;
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Phase I Clinical Study of Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer
This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The investigational approach consists of a single 8 Gy/1 fraction radiotherapy dose delivered to the central subregion of the primary tumor, with rapid dose fall-off to keep the peripheral tumor margin dose below 4 Gy, followed by one cycle of PD-(L)1 inhibitor, and then standard concurrent chemoradiotherapy (cCRT) approximately one week later. Patients without disease progression after cCRT will subsequently receive consolidation immune checkpoint inhibitor therapy.
The primary objective is to assess the safety and feasibility of this lead-in immune-priming strategy, particularly whether it can be integrated into standard cCRT and subsequent immunotherapy without unacceptable toxicity or treatment delay. The primary endpoint is the dose-limiting toxicity (DLT) rate, with the DLT observation window defined from initiation of the priming radiotherapy to 6-8 weeks after completion of cCRT. Secondary objectives include the on-time initiation rate of cCRT, cCRT completion rate, initiation rate of consolidation immunotherapy, acute and subacute toxicity profile, preliminary efficacy signals, and dynamic changes in peripheral lymphocyte counts. Exploratory analyses will investigate peripheral immune cell subsets, circulating tumor DNA (ctDNA), T-cell receptor (TCR) clonality, cytokine changes, and their associations with toxicity and clinical outcomes. The study will adopt a safety run-in plus expansion design, with an initial cohort of 6 patients and expansion to 24 patients if safety is acceptable.
- Being tested
- Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent ChemoradiotherapyRadiation
Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core | Experimental | Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy Receives: Radiation: Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) rate
Measured: From the start of priming radiotherapy to 6-8 weeks after completion of cCRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 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 CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive a single 8 Gy/1 fraction immune-priming irradiation to the central subregion of the pulmonary primary lesion (with edge dose to the primary lesion \<4 Gy), together with one cycle of immune checkpoint inhibitor therapy. Approximately 1 week later, patients will proceed to standard cCRT (60 Gy/30 fractions plus platinum-doublet chemotherapy), followed by sequential immune checkpoint inhibitor consolidation therapy in those without progression.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523464
- Sponsor's protocol ID
- 2026ky476
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase I Clinical Study of Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07523464
- Acronym / sponsor ID
- 2026ky476
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 13 Apr 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.
This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The investigational approach consists of a single 8 Gy/1 fraction radiotherapy dose delivered to the central subregion of the primary tumor, with rapid dose fall-off to keep the peripheral tumor margin dose below 4 Gy, followed by one cycle of PD-(L)1 inhibitor, and then standard concurrent chemoradiotherapy (cCRT) approximately one week later. Patients without disease progression after cCRT will subsequently receive consolidation immune checkpoint inhibitor therapy.
The primary objective is to assess the safety and feasibility of this lead-in immune-priming strategy, particularly whether it can be integrated into standard cCRT and subsequent immunotherapy without unacceptable toxicity or treatment delay. The primary endpoint is the dose-limiting toxicity (DLT) rate, with the DLT observation window defined from initiation of the priming radiotherapy to 6-8 weeks after completion of cCRT. Secondary objectives include the on-time initiation rate of cCRT, cCRT completion rate, initiation rate of consolidation immunotherapy, acute and subacute toxicity profile, preliminary efficacy signals, and dynamic changes in peripheral lymphocyte counts. Exploratory analyses will investigate peripheral immune cell subsets, circulating tumor DNA (ctDNA), T-cell receptor (TCR) clonality, cytokine changes, and their associations with toxicity and clinical outcomes. The study will adopt a safety run-in plus expansion design, with an initial cohort of 6 patients and expansion to 24 patients if safety is acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive a single 8 Gy/1 fraction immune-priming irradiation to the central subregion of the pulmonary primary lesion (with edge dose to the primary lesion <4 Gy), together with one cycle of immune checkpoint inhibitor therapy. Approximately 1 week later, patients will proceed to standard cCRT (60 Gy/30 fractions plus platinum-doublet chemotherapy), followed by sequential immune checkpoint inhibitor consolidation therapy in those without progression.
| Arm | Type | Receives |
|---|---|---|
| Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core | Experimental | Radiation: Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent ChemoradiotherapyCentrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years;
- Histologically or cytologically confirmed NSCLC;
- Unresectable stage III disease according to the AJCC 8th edition;
- Negative for driver gene alterations;
- Considered suitable for definitive cCRT by MDT discussion or investigator judgment;
Key exclusion criteria (9 listed)
- Presence of distant metastasis;
- Positive driver gene alterations;
- Prior definitive thoracic radiotherapy or prior systemic antitumor treatment for the current disease;
- Active autoimmune disease or need for long-term systemic immunosuppressive therapy;
- Active interstitial lung disease, prior severe radiation pneumonitis, or immune-related pneumonitis;
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 |
|---|---|---|
| Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent ChemoradiotherapyCentrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy | Radiation | Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core |
Primary outcome
Dose-limiting toxicity (DLT) rate
Time frame: From the start of priming radiotherapy to 6-8 weeks after completion of cCRT
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 13 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Centrally Confined 8 Gy/1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in people with Locally-Advanced Non-Small Cell Lung Cancer and Radiotherapy, run by Anhui Provincial Hospital.
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 9 inclusion and 9 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiao-yang Li (18701851829, drxyl@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) rate (time frame: From the start of priming radiotherapy to 6-8 weeks after completion of cCRT). 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 13 Apr 2026.