Non-small Cell Lung CancerPhase 2NCT06205927

Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Standard carbon ion beam radiotherapy and Carbon ion beam radiotherapy simultaneously dose boost in people with Non-small Cell Lung Cancer, run by Jian Chen at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Standard carbon ion beam radiotherapy and Carbon ion beam radiotherapy simultaneously dose boost
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteChina
Study dates: 7 Dec 2023to 31 Dec 2026
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between the ages of 18 and 80.
ECOG general status score of 0-2 .
Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.
Medically inoperable, or patient refuses surgery.
Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%, DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin <1.5 times the upper limit of normal value, and AST, ALT<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein <2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.
Sign the informed consent.

Who cannot join

Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
Patient fails to comply with the treatment protocol.
Complicated with other malignant tumors that have not been controlled.
Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
Chest radiation therapy or radioactive particle implantation history.
Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.

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Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
A history of mental illness may hinder the completion of treatment.
With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
Other circumstances that the physician considers inappropriate to participate in clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Li contact

86-21-38296678

jing.li@sphic.org.cn

China1 site, 1 recruiting

Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201513
Jing Li, 86-21-38296678, jing.li@sphic.org.cn
Kun Liu, 86-21-38296678, kun.liu@sphic.org.cn
Recruiting

Other trials in China

About this study

Official title: Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer

The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PET/CT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center. The patients will be randomly divided into two arms: standard treatment arm and hypoxic lesions dose boost arm. The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.

Researchers will compare the local progression-free survival of two groups (primary endpoint), progression-free survival (secondary endpoint), overall survival (secondary endpoint), response rate (secondary endpoint), factional hypoxia volume (FHV) reduction rate (secondary endpoint) and toxicities (secondary endpoint).

Conditions: Non-small Cell Lung Cancer
Being tested: Standard carbon ion beam radiotherapy, Carbon ion beam radiotherapy simultaneously dose boost
Keywords: 18Fluoro-misonidazole, hypoxia, particle therapy, carbon-ion radiotherapy, non-small cell lung cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard carbon ion beam radiotherapyRadiation
The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.
Carbon ion beam radiotherapy simultaneously dose boostRadiation
The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.

Study groups in NCT06205927
Study group	Role	What they receive
Standard treatment arm	Active comparator	The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. Receives: Radiation: Standard carbon ion beam radiotherapy
Boost arm	Experimental	Boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT Receives: Radiation: Carbon ion beam radiotherapy simultaneously dose boost

What is being measured

The primary outcome is the main question the study is designed to answer.

Local progression-free survival
Local progression-free survival was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up
Measured: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months

Secondary outcomes (5)

Disease progression-free survival rate
Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up
Measured: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival rate
Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Measured: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
Overall response rate
Proportion of complete response and partial response in all patients
Measured: From date of radiotherapy started until 6 months after first radiotherapy
Change of fractional hypoxia volume
The hypoxia volume of the hypoxia-positive region of interested was defined as the sum of pixels with a tumor muscle rate ≥1.4. The FHV, defined as the HV-to-gross tumour volume ratio. The FHV before and after carbon ion radiotherapy within 1 month will be recorded.
Measured: From date of radiotherapy started until 1 month after first radiotherapy
Incidence of Treatment-induced Adverse Events
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and EORTC/RTOG criteria, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Measured: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202331 Dec 2026

First posted16 Jan 2024
Study start7 Dec 2023
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2026 (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.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 77 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06205927
Sponsor's protocol ID: SPHIC-TR-THLC2023-02
Status last verified: Jun 2025
First submitted: 17 Dec 2023
Last updated: 17 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06205927
Acronym / sponsor ID: SPHIC-TR-THLC2023-02
Conditions: Non-small Cell Lung Cancer
Keywords: 18Fluoro-misonidazole, hypoxia, particle therapy, carbon-ion radiotherapy, non-small cell lung cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 77 participants (estimated)
Lead sponsor: Jian ChenUniversity, hospital or other
Study start: 7 Dec 2023 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 16 Jan 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard treatment arm	Active comparator	Radiation: Standard carbon ion beam radiotherapyThe standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.
Boost arm	Experimental	Radiation: Carbon ion beam radiotherapy simultaneously dose boostBoost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Between the ages of 18 and 80.
ECOG general status score of 0-2 .
Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.
Medically inoperable, or patient refuses surgery.
Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%, DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin <1.5 times the upper limit of normal value, and AST, ALT<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein <2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.

Key exclusion criteria (11 listed)

Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
Patient fails to comply with the treatment protocol.
Complicated with other malignant tumors that have not been controlled.
Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
Chest radiation therapy or radioactive particle implantation history.

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
Standard carbon ion beam radiotherapyThe standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.	Radiation	Standard treatment arm
Carbon ion beam radiotherapy simultaneously dose boostThe hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.	Radiation	Boost arm

Primary outcome

Local progression-free survival
Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months
Local progression-free survival was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up

5 secondary outcomes

Disease progression-free survival rate
Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival rate
Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
Overall response rate
Time frame: From date of radiotherapy started until 6 months after first radiotherapy
Change of fractional hypoxia volume
Time frame: From date of radiotherapy started until 1 month after first radiotherapy
Incidence of Treatment-induced Adverse Events
Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months

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 17 Jun 2025.
Individual participant dataSharing planned: Undecided

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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.

Jing Li contact

86-21-38296678

jing.li@sphic.org.cn

Jingfang Mao, PHD study chair

Shanghai Proton and Heavy Ion Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. 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 Jing Li (86-21-38296678, jing.li@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local progression-free survival (time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205927.

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 17 Jun 2025.