Early-stage Peripheral Non-small Cell Lung CancerPhase 2NCT07167459
Personalized SBRT in Early-Stage Peripheral NSCLC
A Phase 2 study testing ndividualized Stereotactic Body Radiotherapy (SBRT) System in people with Early-stage Peripheral Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
This study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-stage Peripheral Non-small Cell Lung Cancer
- What is being tested?
- ndividualized Stereotactic Body Radiotherapy (SBRT) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 2 sitesChina
- Study dates
- 4 Aug 2023to 1 Mar 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant or legal guardian provides written informed consent.
- Age ≥18 years; no upper age limit; male or female.
- Pathologically confirmed non-small-cell lung cancer (NSCLC) staged T1-2N0M0 (IA-IIA, AJCC 8th ed.).
- Peripheral tumor location: ≥2 cm from the proximal bronchial tree or any mediastinal structure.
- Medically inoperable (e.g., FEV1 <40 % predicted, DLCO <40 % predicted, NYHA class III-IV heart failure) or refusal of surgery.
- ECOG performance status 0-2.
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- Life expectancy ≥6 months per investigator judgment.
- Measurable disease by RECIST 1.1.
- Adequate organ function (blood counts, liver and renal indices) per institutional standards.
- Willing and able to comply with all study procedures, imaging schedules, and follow-up visits.
- Effective contraception for women of child-bearing potential and fertile men for 12 months after SBRT completion.
Who cannot join
- Previous thoracic radiotherapy, chemotherapy, targeted therapy, or surgery for lung cancer.
- Evidence of regional or distant metastases.
- Concurrent or prior malignancy within 5 years (except adequately treated basal-cell carcinoma of skin or carcinoma in situ of cervix).
- Active interstitial pneumonitis, radiation pneumonitis, drug-induced pneumonitis, or clinically significant pulmonary fibrosis.
- Pregnancy, lactation, or planned pregnancy.
- Participation in another interventional clinical trial with an unmet primary endpoint.
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- Known psychiatric disorder, substance abuse, or other condition that would impair compliance.
- Contraindication to contrast-enhanced CT or PET-CT imaging.
- Investigator-determined medical, social, or psychological contraindications that could compromise safety or data integrity.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality, 300381
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality
About this study
Official title: A Phase II Trial of Personalized Definitive Stereotactic Body Radiotherapy (SBRT) for Early-Stage Peripheral Non-Small Cell Lung Cancer (NSCLC) With Correlative Omics Analysis
This study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). Individualized SBRT is a specialized radiation technique that delivers precise, high-dose treatment while minimizing damage to surrounding normal tissues.
The main question it aims to answer is:
Read more
Does individualized SBRT maintain local tumor control and patient survival at 3 years without significant side effects?
Patients with early-stage peripheral NSCLC who are medically inoperable or refuse surgery, and who are scheduled to receive individualized SBRT as their standard treatment, will provide the data to assess the safety and efficacy of this personalized radiation approach.
- Being tested
- ndividualized Stereotactic Body Radiotherapy (SBRT) System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ndividualized Stereotactic Body Radiotherapy (SBRT) SystemDevice
The individualized SBRT system employs advanced image-guided radiation delivery to deliver highly conformal, ablative doses to early-stage peripheral non-small-cell lung cancer while minimizing exposure to surrounding normal tissues. Treatment is delivered via a state-of-the-art robotic radiosurgery platform (e.g., CyberKnife M6) according to patient-specific fractionation schedules based on tumor size and proximity to critical structures, following standard indications and institutional protocols for medically inoperable or surgically refused cases.
| Study group | Role | What they receive |
|---|---|---|
| Individualized SBRT for Early-Stage Peripheral NSCLC | Experimental | This single-arm cohort comprises patients with newly diagnosed, early-stage peripheral non-small-cell lung cancer (T1-2N0M0, IA-IIA) who receive individualized stereotactic body radiotherapy (SBRT) as standard-of-care. Participants will be prospectively followed for 3 years to assess overall survival, local control, progression-free survival, and adverse events. Inclusion criteria: age ≥18 years, pathologically confirmed NSCLC, tumor location ≥2 cm from the proximal bronchial tree, ECOG 0-2, and medically inoperable or refusal of surgery. Receives: Device: ndividualized Stereotactic Body Radiotherapy (SBRT) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival (OS)
Three-year overall survival is defined as the proportion of participants who remain alive at 36 months from the start of individualized stereotactic body radiotherapy (SBRT).
Measured: Approximately 36 months after enrollment
Secondary outcomes (4)
3-year Progression-Free Survival (PFS)
Proportion of participants alive and without radiographic progression at 36 months.
Measured: Enrollment → 36 months
3-year Local Control (LC)
Proportion of participants with no evidence of tumor recurrence at the irradiated site at 36 months.
Measured: Enrollment → 36 months
Objective Response Rate (ORR)
Percentage of participants achieving complete or partial response per RECIST 1.1 at 4 months after SBRT completion.
Measured: Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up)
Adverse Event Incidence
Frequency and severity of all treatment-related toxicities graded by CTCAE 5.0, collected continuously.
Measured: Enrollment → 6 months after last SBRT fraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start4 Aug 2023
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Peripheral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167459
- Sponsor's protocol ID
- E20230372
- Other IDs
- TZ3582022-005
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Personalized Definitive Stereotactic Body Radiotherapy (SBRT) for Early-Stage Peripheral Non-Small Cell Lung Cancer (NSCLC) With Correlative Omics Analysis
- ClinicalTrials.gov ID
- NCT07167459
- Acronym / sponsor ID
- E20230372
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 251 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 11 Sep 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 study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). Individualized SBRT is a specialized radiation technique that delivers precise, high-dose treatment while minimizing damage to surrounding normal tissues.
The main question it aims to answer is:
Does individualized SBRT maintain local tumor control and patient survival at 3 years without significant side effects?
Patients with early-stage peripheral NSCLC who are medically inoperable or refuse surgery, and who are scheduled to receive individualized SBRT as their standard treatment, will provide the data to assess the safety and efficacy of this personalized radiation approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized SBRT for Early-Stage Peripheral NSCLC | Experimental | Device: ndividualized Stereotactic Body Radiotherapy (SBRT) SystemThis single-arm cohort comprises patients with newly diagnosed, early-stage peripheral non-small-cell lung cancer (T1-2N0M0, IA-IIA) who receive individualized stereotactic body radiotherapy (SBRT) as standard-of-care. Participants will be prospectively followed for 3 years to assess overall survival, local control, progression-free survival, and adverse events. Inclusion criteria: age ≥18 years, pathologically confirmed NSCLC, tumor location ≥2 cm from the proximal bronchial tree, ECOG 0-2, and medically inoperable or refusal of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant or legal guardian provides written informed consent.
- Age ≥18 years; no upper age limit; male or female.
- Pathologically confirmed non-small-cell lung cancer (NSCLC) staged T1-2N0M0 (IA-IIA, AJCC 8th ed.).
- Peripheral tumor location: ≥2 cm from the proximal bronchial tree or any mediastinal structure.
- Medically inoperable (e.g., FEV1 <40 % predicted, DLCO <40 % predicted, NYHA class III-IV heart failure) or refusal of surgery.
Key exclusion criteria (9 listed)
- Previous thoracic radiotherapy, chemotherapy, targeted therapy, or surgery for lung cancer.
- Evidence of regional or distant metastases.
- Concurrent or prior malignancy within 5 years (except adequately treated basal-cell carcinoma of skin or carcinoma in situ of cervix).
- Active interstitial pneumonitis, radiation pneumonitis, drug-induced pneumonitis, or clinically significant pulmonary fibrosis.
- Pregnancy, lactation, or planned pregnancy.
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 |
|---|---|---|
| ndividualized Stereotactic Body Radiotherapy (SBRT) SystemThe individualized SBRT system employs advanced image-guided radiation delivery to deliver highly conformal, ablative doses to early-stage peripheral non-small-cell lung cancer while minimizing exposure to surrounding normal tissues. Treatment is delivered via a state-of-the-art robotic radiosurgery platform (e.g., CyberKnife M6) according to patient-specific fractionation schedules based on tumor size and proximity to critical structures, following standard indications and institutional protocols for medically inoperable or surgically refused cases. | Device | Individualized SBRT for Early-Stage Peripheral NSCLC |
Primary outcome
3-year overall survival (OS)
Time frame: Approximately 36 months after enrollment
Three-year overall survival is defined as the proportion of participants who remain alive at 36 months from the start of individualized stereotactic body radiotherapy (SBRT).
4 secondary outcomes
3-year Progression-Free Survival (PFS)
Time frame: Enrollment → 36 months
3-year Local Control (LC)
Time frame: Enrollment → 36 months
Objective Response Rate (ORR)
Time frame: Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up)
Adverse Event Incidence
Time frame: Enrollment → 6 months after last SBRT fraction
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 11 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ndividualized Stereotactic Body Radiotherapy (SBRT) System in people with Early-stage Peripheral Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites 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 11 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (OS) (time frame: Approximately 36 months after enrollment). 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 11 Sep 2025.