Non-Small Cell Lung CancerPhase 2NCT07919691
Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
A Phase 2 study testing Proton radiotherapy in people with Non-Small Cell Lung Cancer, run by Ruijin Hospital.
Trial summary
The goal of this clinical trial is to learn if proton moderately hypofractionated radiotherapy works to treat non-small cell lung cancer in adults who cannot tolerate standard concurrent chemoradiotherapy. It will also learn about the safety of this treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Proton radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Dec 2030
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent before any study-specific procedure.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Locally advanced (stage IIIA-IIIC) or oligometastatic NSCLC for which thoracic moderately hypofractionated radiotherapy is planned.
- Meets at least one of the following criteria defining inability to tolerate standard concurrent chemoradiotherapy: Frailty/older age: age ≥70 years AND Charlson Comorbidity Index (CCI) ≥1; OR Moderate or worse pulmonary function impairment: GOLD moderate or worse ventilatory impairment (FEV1/FVC <0.70 AND FEV1 ≤80% predicted) OR DLCO ≤60% predicted; OR Interstitial lung disease/pulmonary fibrosis confirmed by high-resolution chest CT or pathology, including idiopathic pulmonary fibrosis (IPF), nonspecific interstitial pneumonia (NSIP), connective tissue disease-associated ILD (CTD-ILD), and other ILD types, AND clinically stable with no evidence of acute exacerbation within the past 3 months.
- Age ≥18 years and ≤ 85 years.
- Expected survival >6 months.
- Assessed by a multidisciplinary team (including radiation oncology, respiratory medicine, and radiology) as having an indication for radiotherapy and being able to tolerate proton therapy.
Who cannot join
- Extensive distant metastasis (non-oligometastatic disease, defined as >5 metastatic lesions or >2 involved organs).
- Prior thoracic radiotherapy.
- Pregnancy or breastfeeding.
- Severe uncontrolled non-neoplastic medical comorbidity (e.g., severe cardiac, hepatic, or renal insufficiency).
- History of acute exacerbation of ILD within the past 3 months (confirmed by a respiratory medicine physician).
- Active infection or fever.
- History of another malignancy within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or similar cured malignancies.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for study enrollment.
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 Prospective Clinical Study of Proton Moderately Hypofractionated Radiotherapy for Non-Small Cell Lung Cancer Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
The goal of this clinical trial is to learn if proton moderately hypofractionated radiotherapy works to treat non-small cell lung cancer in adults who cannot tolerate standard concurrent chemoradiotherapy. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does proton moderately hypofractionated radiotherapy improve the 1-year overall survival rate compared with historical data from similar patients? What medical problems do participants have during and after this treatment? This is a single-arm study, so all participants will receive proton radiotherapy. Researchers will compare results with historical control data, not with a placebo group. Participants will: Receive proton radiotherapy once daily for about 3 to 4 weeks.
Have checkups and tests before treatment, weekly during treatment, and regularly after treatment. Complete follow-up visits for at least 2 years, including imaging, blood tests, lung function tests, and quality-of-life questionnaires.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Proton radiotherapy
- Keywords
- non-small-cell lung cancer, proton radiotherapy, elderly, fragile, moderately hypofractionated radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiotherapyRadiation
Thoracic intensity-modulated proton therapy (IMPT) delivered as moderately hypofractionated radiotherapy. The standard prescription is 54 GyE in 18 fractions (3 GyE per fraction), with protocol-defined de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions for patients who cannot meet normal-tissue constraints or are at very high risk; doses below 48 GyE/16 fractions are not permitted. This intervention is distinguished from standard photon concurrent chemoradiotherapy by the use of proton therapy, omission of concurrent chemotherapy, a shorter 3-4 week course, and prespecified planning priorities that include target coverage, standard organ-at-risk limits, lymphocyte-sparing organ constraints, and optional esophageal sparing. Patients with interstitial lung disease receive stricter lung dose constraints. IMPT plans are robustly optimized for 3.5% range uncertainty and 3 mm setup uncertainty. No placebo or comparator is
| Study group | Role | What they receive |
|---|---|---|
| Proton Moderately Hypofractionated Radiotherapy | Experimental | All participants will receive thoracic proton moderately hypofractionated radiotherapy as a single-arm intervention. The standard regimen is 54 GyE in 18 fractions (3 GyE per fraction). For patients who cannot meet normal-tissue dose constraints or are at very high risk, prespecified de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions is permitted; doses below 48 GyE/16 fractions require study withdrawal. Treatment planning prioritizes target coverage (Clinical target volume, CTV V95 ≥95%, Gross tumor volume, GTV V100 ≥100%) while respecting standard organ-at-risk constraints, lymphocyte-sparing organ constraints, and additional esophageal sparing where feasible. Patients with interstitial lung disease receive stricter lung dose limits. No placebo or comparator intervention is administered; outcomes will be compared with historical control data. Receives: Radiation: Proton radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Overall Survival (OS) Rate
Proportion of participants alive at 1 year after initiation of proton radiotherapy. Survival time is defined from the start of radiotherapy to death from any cause or last follow-up; participants lost to follow-up will be censored.
Measured: 1 year from the start of radiotherapy
Secondary outcomes (6)
Progression-free survival (PFS)
Time from start of radiotherapy to disease progression or death from any cause, whichever occurs first.
Measured: From start of radiotherapy up to 2 years
Local control (LC)
Time from start of radiotherapy to imaging-documented progression within the target volume (GTV/CTV).
Measured: From start of radiotherapy up to 2 years
Incidence of grade ≥2 radiation pneumonitis
Proportion of participants with grade ≥2 radiation pneumonitis according to Common Terminology Criteria for Adverse Events Version (CTCAE) v5.0.
Measured: Within 6 months after completion of radiotherapy
Change in pulmonary function
Change in Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity(FVC), and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) from baseline to post-radiotherapy assessments.
Measured: Baseline, and 3, 6, and 12 months after radiotherapy
Incidence of grade ≥3 lymphopenia
Proportion of participants with grade ≥3 lymphopenia according to CTCAE v5.0.
Measured: During radiotherapy and up to 3 months after completion of radiotherapy
Incidence of grade ≥3 hematologic toxicity
Proportion of participants with grade ≥3 leukopenia, neutropenia, or thrombocytopenia according to CTCAE v5.0.
Measured: During radiotherapy and up to 3 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QI WEIXIANG，MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919691
- Sponsor's protocol ID
- 2026-829
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small, single-arm, investigator-initiated trial in a rare high-risk population; the informed consent and ethics approval cover only aggregate reporting, and the limited number of participants creates a meaningful risk of re-identification. Only de-identified aggregate results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Proton Moderately Hypofractionated Radiotherapy for Non-Small Cell Lung Cancer Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT07919691
- Acronym / sponsor ID
- 2026-829
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small-cell lung cancer, proton radiotherapy, elderly, fragile, moderately hypofractionated radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Nov 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.
The goal of this clinical trial is to learn if proton moderately hypofractionated radiotherapy works to treat non-small cell lung cancer in adults who cannot tolerate standard concurrent chemoradiotherapy. It will also learn about the safety of this treatment. The main questions it aims to answer are: Does proton moderately hypofractionated radiotherapy improve the 1-year overall survival rate compared with historical data from similar patients? What medical problems do participants have during and after this treatment? This is a single-arm study, so all participants will receive proton radiotherapy. Researchers will compare results with historical control data, not with a placebo group. Participants will: Receive proton radiotherapy once daily for about 3 to 4 weeks.
Have checkups and tests before treatment, weekly during treatment, and regularly after treatment. Complete follow-up visits for at least 2 years, including imaging, blood tests, lung function tests, and quality-of-life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Moderately Hypofractionated Radiotherapy | Experimental | Radiation: Proton radiotherapyAll participants will receive thoracic proton moderately hypofractionated radiotherapy as a single-arm intervention. The standard regimen is 54 GyE in 18 fractions (3 GyE per fraction). For patients who cannot meet normal-tissue dose constraints or are at very high risk, prespecified de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions is permitted; doses below 48 GyE/16 fractions require study withdrawal. Treatment planning prioritizes target coverage (Clinical target volume, CTV V95 ≥95%, Gross tumor volume, GTV V100 ≥100%) while respecting standard organ-at-risk constraints, lymphocyte-sparing organ constraints, and additional esophageal sparing where feasible. Patients with interstitial lung disease receive stricter lung dose limits. No placebo or comparator intervention is administered; outcomes will be compared with historical control data. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of written informed consent before any study-specific procedure.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Locally advanced (stage IIIA-IIIC) or oligometastatic NSCLC for which thoracic moderately hypofractionated radiotherapy is planned.
- Meets at least one of the following criteria defining inability to tolerate standard concurrent chemoradiotherapy: Frailty/older age: age ≥70 years AND Charlson Comorbidity Index (CCI) ≥1; OR Moderate or worse pulmonary function impairment: GOLD moderate or worse ventilatory impairment (FEV1/FVC <0.70 AND FEV1 ≤80% predicted) OR DLCO ≤60% predicted; OR Interstitial lung disease/pulmonary fibrosis confirmed by high-resolution chest CT or pathology, including idiopathic pulmonary fibrosis (IPF), nonspecific interstitial pneumonia (NSIP), connective tissue disease-associated ILD (CTD-ILD), and other ILD types, AND clinically stable with no evidence of acute exacerbation within the past 3 months.
- Age ≥18 years and ≤ 85 years.
Key exclusion criteria (8 listed)
- Extensive distant metastasis (non-oligometastatic disease, defined as >5 metastatic lesions or >2 involved organs).
- Prior thoracic radiotherapy.
- Pregnancy or breastfeeding.
- Severe uncontrolled non-neoplastic medical comorbidity (e.g., severe cardiac, hepatic, or renal insufficiency).
- History of acute exacerbation of ILD within the past 3 months (confirmed by a respiratory medicine physician).
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 |
|---|---|---|
| Proton radiotherapyThoracic intensity-modulated proton therapy (IMPT) delivered as moderately hypofractionated radiotherapy. The standard prescription is 54 GyE in 18 fractions (3 GyE per fraction), with protocol-defined de-escalation to 51 GyE/17 fractions or 48 GyE/16 fractions for patients who cannot meet normal-tissue constraints or are at very high risk; doses below 48 GyE/16 fractions are not permitted. This intervention is distinguished from standard photon concurrent chemoradiotherapy by the use of proton therapy, omission of concurrent chemotherapy, a shorter 3-4 week course, and prespecified planning priorities that include target coverage, standard organ-at-risk limits, lymphocyte-sparing organ constraints, and optional esophageal sparing. Patients with interstitial lung disease receive stricter lung dose constraints. IMPT plans are robustly optimized for 3.5% range uncertainty and 3 mm setup uncertainty. No placebo or comparator is | Radiation | Proton Moderately Hypofractionated Radiotherapy |
Primary outcome
1-Year Overall Survival (OS) Rate
Time frame: 1 year from the start of radiotherapy
Proportion of participants alive at 1 year after initiation of proton radiotherapy. Survival time is defined from the start of radiotherapy to death from any cause or last follow-up; participants lost to follow-up will be censored.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: From start of radiotherapy up to 2 years
Local control (LC)
Time frame: From start of radiotherapy up to 2 years
Incidence of grade ≥2 radiation pneumonitis
Time frame: Within 6 months after completion of radiotherapy
Change in pulmonary function
Time frame: Baseline, and 3, 6, and 12 months after radiotherapy
Incidence of grade ≥3 lymphopenia
Time frame: During radiotherapy and up to 3 months after completion of radiotherapy
Incidence of grade ≥3 hematologic toxicity
Time frame: During radiotherapy and up to 3 months after completion of radiotherapy
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 5 Nov 2026.
- Individual participant dataSharing planned: No. This is a small, single-arm, investigator-initiated trial in a rare high-risk population; the informed consent and ethics approval cover only aggregate reporting, and the limited number of participants creates a meaningful risk of re-identification. Only de-identified aggregate results will be reported.
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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 2 study testing Proton radiotherapy in people with Non-Small Cell Lung Cancer, run by Ruijin 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 7 inclusion and 8 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 5 Nov 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 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 Weixiang Qi, Dr. (+86-021-64370045, qiweixiang1113@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Overall Survival (OS) Rate (time frame: 1 year from the start of radiotherapy). 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 5 Nov 2026.