Non Small Cell Lung Cancer MetastaticNCT07462728
Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer
A study testing Three-Dimensional Radiotherapy for Primary lungTumors in people with Non Small Cell Lung Cancer Metastatic and Radiotherapy, run by Guizhou Medical University.
Trial summary
For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic, Radiotherapy
- What is being tested?
- Three-Dimensional Radiotherapy for Primary lungTumors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Dec 2027
- Phase
- Interventional
- 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
- Pathologically or cytologically confirmed stage IV NSCLC [9th edition, 2024];
- Non-oligometastatic disease (number of metastatic lesions > 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy;
- Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor/ROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy;
- Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK/ROS1 inhibitors, chemotherapy, or immunotherapy;
- No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 >50%, mild to moderate impairment of lung function.
- Signed informed consent before treatment (for radiotherapy, chemotherapy, immunotherapy, and targeted drug therapy);
- Good patient compliance with the treatment and follow-up.
Who cannot join
- Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60;
- Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction;
- Pregnant or lactating patients;
- Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer;
- Patients with allergic constitution or known/suspected allergy to any investigational drugs without alternative medications;
- Patients with poor compliance; Patients deemed unsuitable for participation in this trial by the investigator.
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
For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.
- Being tested
- Three-Dimensional Radiotherapy for Primary lungTumors
- Keywords
- non-oligometastatic NSCLC, radical radiotherapy of the primary lung lesion, pharmacotherapy with radiotherapy for the primary lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Radiotherapy for Primary lungTumorsRadiation
The experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacotherapy group | No intervention | For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. |
| Radiotherapy group | Experimental | For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. Concurrent radiotherapy for the primary tumor in combination with drug therapy. Receives: Radiation: Three-Dimensional Radiotherapy for Primary lungTumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival, Local regional progressive-free survival, LRPFS
OS refers to the period the date of randomization in a clinical trial until the patient dies from any cause.
Local progression-free survival time refers to the duration from randomization until the first occurrence of local progression at the primary tumor site or region, or death from any cause
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (3)
ORR,
ORR define the objective response rate according to RECIST version 1.1.
Measured: From enrollment to the end of treatment at 1year.
PFS
PFS, definehe length of time during and after treatment that a patient lives with the disease but it does not get worse. It is typically measured from the start of treatment until disease progression or death from any cause.
Measured: From enrollment to the end of treatment at 1 year
Toxicities
Toxicities: The primary assessment of radiotherapy-related toxicities is based on the CTC 5.0 criteria, focusing on treatment-related toxicities such as radiation pneumonitis, radiation esophagitis, bone marrow suppression, and hematologic toxicities affecting the liver and kidneys. And the time without cancer worsening or death
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (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 Cancer MetastaticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462728
- Sponsor's protocol ID
- FZ 2025-09-246
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07462728
- Acronym / sponsor ID
- FZ 2025-09-246
- Keywords
- non-oligometastatic NSCLC, radical radiotherapy of the primary lung lesion, pharmacotherapy with radiotherapy for the primary lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Mar 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.
For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacotherapy group | No intervention | –For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. |
| Radiotherapy group | Experimental | Radiation: Three-Dimensional Radiotherapy for Primary lungTumorsFor patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. Concurrent radiotherapy for the primary tumor in combination with drug therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically or cytologically confirmed stage IV NSCLC [9th edition, 2024];
- Non-oligometastatic disease (number of metastatic lesions > 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy;
- Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor/ROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy;
- Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK/ROS1 inhibitors, chemotherapy, or immunotherapy;
- No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 >50%, mild to moderate impairment of lung function.
Key exclusion criteria (7 listed)
- Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60;
- Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction;
- Pregnant or lactating patients;
- Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer;
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 |
|---|---|---|
| Three-Dimensional Radiotherapy for Primary lungTumorsThe experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines. | Radiation | Radiotherapy group |
Primary outcome
Overall Survival, Local regional progressive-free survival, LRPFS
Time frame: From enrollment to the end of treatment at 1 year
OS refers to the period the date of randomization in a clinical trial until the patient dies from any cause. Local progression-free survival time refers to the duration from randomization until the first occurrence of local progression at the primary tumor site or region, or death from any cause
3 secondary outcomes
ORR,
Time frame: From enrollment to the end of treatment at 1year.
PFS
Time frame: From enrollment to the end of treatment at 1 year
Toxicities
Time frame: From enrollment to the end of treatment at 1 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 10 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Dimensional Radiotherapy for Primary lungTumors in people with Non Small Cell Lung Cancer Metastatic and Radiotherapy, run by Guizhou Medical University.
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 7 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 10 Mar 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.
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 Bing Lu (+86 13809432527, lbgymaaaa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival, Local regional progressive-free survival, LRPFS (time frame: From enrollment to the end of treatment at 1 year). 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 10 Mar 2026.