ImmunotherapyNCT05909137
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
An observational study of Immunotherapy and Intensity Modulated Radiation Therapy, run by Xinqiao Hospital of Chongqing.
Trial summary
Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunotherapy, Intensity Modulated Radiation Therapy, Radiotherapy
- What is being tested?
- IMRT+adjuvant immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.
Who may be able to join
- •Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
- ECOG whole body status (performancestatus,PS) level 0 or 1
- The estimated survival time is more than 12 weeks, 18 ~80 years old
- Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count > 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet > 50,000/ MCL; ③ Total bilirubin < 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) < 2.5 times of the normal upper limit; ⑤ Serum creatinine < 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
- Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
- Understand and voluntarily sign written informed consent
- The investigator judged that the patient had good compliance
Who cannot join
- Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy
- Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc.
- Pregnant or nursing women
- The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
- HIV-positive patients receiving combination antiretroviral therapy
- Active tuberculosis
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- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- Prior allogeneic stem cell or solid organ transplantation
- Researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
tianxiang cui contact
About this study
Official title: Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis.
The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.
- Being tested
- IMRT+adjuvant immunotherapy
- Keywords
- IMRT, immunotherapy, CTV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT+adjuvant immunotherapyRadiation
The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT and the control group with CTV-delineated IMRT using a random number table.
| Study group | Role | What they receive |
|---|---|---|
| study group | CTV-omitted IMRT+adjuvant immunotherapy Receives: Radiation: IMRT+adjuvant immunotherapy | |
| control group | CTV-delineated IMRT+adjuvant immunotherapy Receives: Radiation: IMRT+adjuvant immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time between randomization and the first occurrence of disease progression or die
Measured: through study completion，up to 12 weeks
radiation respiratory events or esophagitis with grade 3 or higher
Measured: after radiation therapy，up to 1 year
Secondary outcomes (1)
Overall survival
Time from randomization to death from any cause
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909137
- Sponsor's protocol ID
- XQonc-022
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05909137
- Acronym / sponsor ID
- XQonc-022
- Keywords
- IMRT, immunotherapy, CTV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 2023 (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.
Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis.
The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Radiation: IMRT+adjuvant immunotherapyCTV-omitted IMRT+adjuvant immunotherapy |
| control group | – | Radiation: IMRT+adjuvant immunotherapyCTV-delineated IMRT+adjuvant immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced (Stage IIIa or IIIb) NSCLC that was histologically or cytologically inoperable.
Key inclusion criteria (7 listed)
- •Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
Key exclusion criteria (9 listed)
- Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy
- Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc.
- Pregnant or nursing women
- The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
- HIV-positive patients receiving combination antiretroviral therapy
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 |
|---|---|---|
| IMRT+adjuvant immunotherapyThe enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT and the control group with CTV-delineated IMRT using a random number table. | Radiation | control group, study group |
Primary outcome
Progression-free survival
Time frame: through study completion，up to 12 weeks
The time between randomization and the first occurrence of disease progression or die
radiation respiratory events or esophagitis with grade 3 or higher
Time frame: after radiation therapy，up to 1 year
1 secondary outcome
Overall survival
Time frame: through study completion, an average of 2 year
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 14 Jul 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.
tianxiang cui contact
Questions about this trial
What is this clinical trial studying?
An observational study of Immunotherapy and Intensity Modulated Radiation Therapy, run by Xinqiao Hospital of Chongqing.
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 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 14 Jul 2025. 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.
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 jianguo sun, Phd (023-68774490 ext. 0086, sunjg09@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: through study completion，up to 12 weeks). 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 14 Jul 2025.