A Phase 2 interventional study of Proton radiotherapy in Non-Small Cell Lung Cancer, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 44 is below the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: Proton radiotherapy
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
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.
Time frame: 1 year from the start of radiotherapy
Progression-free survival (PFS)
Time from start of radiotherapy to disease progression or death from any cause, whichever occurs first.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During radiotherapy and up to 3 months after completion of radiotherapy
Incidence of grade ≥3 acute radiotherapy-related adverse events
Proportion of participants with any grade ≥3 acute radiotherapy-related adverse event according to CTCAE v5.0.
Time frame: Within 3 months after completion of radiotherapy
Quality of life - European Organisation for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30)
Change in EORTC QLQ-C30 scores from baseline. The QLQ-C30 is a 30-item questionnaire with multi-item functional scales (physical, role, cognitive, emotional, social) and a global health status/QoL scale, scored from 0 to 100, where higher scores indicate better functioning or better quality of life; and symptom scales/items (fatigue, pain, nausea/vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial impact), scored from 0 to 100, where higher scores indicate greater symptom burden or worse status.
Time frame: Baseline, end of radiotherapy (week 4), and 3, 6, and 12 months after radiotherapy.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2030, 43 months later.
Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 43 months is below that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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