Carbon Ion RadiotherayNCT07035860
Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
An observational study of Carbon Ion Radiotheray, run by Ji Yongling at 1 site in China.
Trial summary
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced 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
- Carbon Ion Radiotheray
- What is being tested?
- Carbon ion radiotherapy, Chemotherapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 15 Jun 2028
- Phase
- Observational
- 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
Study population: Patients with unresectable locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
Who may be able to join
- Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
- No prior anti-cancer treatment.
- No significant internal medical conditions or major organ dysfunction.
Who cannot join
- Histological evidence of small cell lung cancer or other primary malignancies
- EGFR, ALK, or ROS-1 gene mutations.
- Active or prior autoimmune/inflammatory disorders.
- Inability to comply with study protocol as judged by the investigator.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yongling Ji, MD, 0086-571-88122088, drjyl@msn.com
Min Fang, 0086-571-88122088, 541387924@qq.com
About this study
Official title: Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
Read the detailed description
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
- Conditions
- Carbon Ion Radiotheray
- Being tested
- Carbon ion radiotherapy, Chemotherapy, Immunotherapy
- Keywords
- non-small cell lung cancer, carbon ion radiotherapy, immunotherapy
- 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.
Carbon ion radiotherapyRadiation
Patients will receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
ChemotherapyDrug
platinum-based doublet chemotherapy
ImmunotherapyDrug
The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
| Study group | Role | What they receive |
|---|---|---|
| Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy | Not described Receives: Radiation: Carbon ion radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year PFS
Time between enrollment and recurrence of disease or death
Measured: 12 months
Incidence of Grade ≥3 Treatment-Related Adverse Events
Safety
Measured: Occurrence or end of follow-up（3 years after enrollment), which comes first
Secondary outcomes (1)
OS
Time between enrollment and death
Measured: Occurrence or end of follow-up（3 years after enrollment）, which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start16 Jun 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Ion RadiotherayStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Yongling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Yongling, Zhejiang Cancer Hospital
- Investigators
- Yongling JI, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035860
- Sponsor's protocol ID
- HZCIRT-Lung 001
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07035860
- Acronym / sponsor ID
- HZCIRT-Lung 001
- Conditions
- Carbon Ion Radiotheray
- Keywords
- non-small cell lung cancer, carbon ion radiotherapy, immunotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ji YonglingUniversity, hospital or other
- Study start
- 16 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 25 Jun 2025 (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 the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
Detailed description
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy | – | Radiation: Carbon ion radiotherapy, Drug: Chemotherapy, Drug: Immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
Key inclusion criteria (3 listed)
- Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
- No prior anti-cancer treatment.
- No significant internal medical conditions or major organ dysfunction.
Key exclusion criteria (4 listed)
- Histological evidence of small cell lung cancer or other primary malignancies
- EGFR, ALK, or ROS-1 gene mutations.
- Active or prior autoimmune/inflammatory disorders.
- Inability to comply with study protocol as judged by the investigator.
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 |
|---|---|---|
| Carbon ion radiotherapyPatients will receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab. | Radiation | Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy |
| Chemotherapyplatinum-based doublet chemotherapy | Drug | Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy |
| ImmunotherapyThe concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab. | Drug | Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy |
Primary outcome
1-year PFS
Time frame: 12 months
Time between enrollment and recurrence of disease or death
Incidence of Grade ≥3 Treatment-Related Adverse Events
Time frame: Occurrence or end of follow-up（3 years after enrollment), which comes first
Safety
1 secondary outcome
OS
Time frame: Occurrence or end of follow-up（3 years after enrollment）, which comes first
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 25 Jun 2025.
- 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.
Yongling JI, MD principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Ion Radiotheray, run by Ji Yongling 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 3 inclusion and 4 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 25 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.
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 Yongling JI, MD (0086-571-88122088, drjyl@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year PFS (time frame: 12 months). 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 25 Jun 2025.