Non Small Cell Lung CancerPhase 3NCT07608159
Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.
A Phase 3 study testing Stereotactic body radiotherapy (SBRT), neoadjuvant immunotherapy and Neoadjuvant Chemotherapy in people with Non Small Cell Lung Cancer and Stereotactic Body Radiotherapy, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Stereotactic Body Radiotherapy, Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Stereotactic body radiotherapy (SBRT), neoadjuvant immunotherapy and Neoadjuvant Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2030
- Phase
- Phase 3
- 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
Who may be able to join
- Male or female participants aged 18 to 75 years;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1;
- Adequate pulmonary function, as assessed by the surgeon, to tolerate the planned lung resection;
- Absence of sensitizing EGFR mutations or ALK rearrangements confirmed by tissue-based molecular pathological testing;
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- Adequate organ function, defined as follows:
- Bone marrow function: absolute neutrophil count ≥1.5 × 10^9/L, platelet count ≥80 × 10^9/L, and hemoglobin ≥9 g/dL; Liver function: total serum bilirubin ≤1.5 × upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤1.5 × upper limit of normal; Renal function: serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥60 mL/min, and blood urea nitrogen ≤200 mg/L;
- Participants must be fully informed about the study and voluntarily sign the written informed consent form.
- Male participants with reproductive potential or female participants of childbearing potential must agree to use effective contraception during the study, such as oral contraceptives, an intrauterine device, or a barrier method combined with spermicide, and continue contraception for 6 months after completion of treatment.
Who cannot join
- Locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the multidisciplinary consensus for stage III non-small cell lung cancer (2019 edition), including some stage IIIA, stage IIIB, and all stage IIIC disease. This usually includes N2 disease with a single-station mediastinal lymph node with a short-axis diameter ≥3 cm, or multistation lymph node fusion/conglomeration with lymph nodes having a short-axis diameter ≥2 cm on CT; T4 disease invading the esophagus, heart, aorta, or pulmonary veins; and all N3 disease;
- Non-small cell lung cancer involving the superior sulcus, large-cell neuroendocrine carcinoma, or sarcomatoid carcinoma;
- Known sensitizing EGFR mutation or ALK rearrangement. For participants with non-squamous histology, EGFR and ALK mutation status must be confirmed;
- Prior treatment with PD-1 or PD-L1 inhibitors, or agents targeting another T-cell receptor pathway, such as CTLA-4 or OX-40;
- Active or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, and inflammatory bowel disease. Exceptions include type 1 diabetes mellitus or hypothyroidism controlled with stable replacement therapy, and dermatologic conditions not requiring systemic treatment, such as psoriasis or vitiligo;
- History of interstitial lung disease of grade 2 or higher;
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- Use of systemic corticosteroids, defined as prednisone >10 mg/day or equivalent, or other immunosuppressive medications within 14 days before the first dose of study treatment;
- History of immunodeficiency, including acquired or congenital immunodeficiency disorders, history of organ transplantation, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Receipt of a live vaccine within 4 weeks before the first dose of study treatment;
- Severe cardiovascular or cerebrovascular disease, including:
- Poorly controlled hypertension or pulmonary hypertension;
- Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation within 6 months before study treatment;
- Chronic heart failure with New York Heart Association class II or higher cardiac function;
- Left ventricular ejection fraction <50%;
- Severe arrhythmias requiring medical treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia. Examples include QTcF >450 msec in males or >470 msec in females, complete left bundle branch block, or third-degree atrioventricular block;
- Cerebrovascular accident or transient ischemic attack within 6 months before study treatment;
- Uncontrolled or severe underlying medical conditions, including but not limited to active infection requiring systemic antibiotic therapy;
- Positive human immunodeficiency virus antibody test, active hepatitis B, or active hepatitis C. The following participants may be eligible:
- Participants positive for hepatitis B core antibody or hepatitis B surface antigen may be enrolled if HBV DNA is below the lower limit of detection at the study site, or <500 IU/mL, and active infection is excluded by the investigator based on clinical treatment history and clinical manifestations;
- Participants positive for hepatitis C antibody may be enrolled if HCV RNA is below the lower limit of detection at the study site;
- Known active pulmonary tuberculosis. Participants suspected of having active tuberculosis must undergo chest X-ray, sputum examination, and assessment of clinical symptoms and signs to exclude active tuberculosis;
- History of any active malignancy other than the study disease within 2 years before enrollment, except malignancies expected to be cured after treatment, including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery;
- History of psychotropic drug abuse that cannot be discontinued, or history of psychiatric disorder;
- Pregnant or breastfeeding women;
- Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with interpretation of the study results.
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
Official title: A Randomized, Controlled, Multicenter Phase III Clinical Study of Spatially Fractionated Stereotactic Body Radiotherapy Plus Toripalimab and Chemotherapy Versus Toripalimab Plus Chemotherapy in Patients With Resectable or Potentially Resectable Stage II-III Non-Small Cell Lung Cancer
This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.
- Conditions
- Non Small Cell Lung Cancer, Stereotactic Body Radiotherapy, Neoadjuvant Chemoimmunotherapy, Surgery
- Being tested
- Stereotactic body radiotherapy (SBRT), neoadjuvant immunotherapy, Neoadjuvant Chemotherapy
- Keywords
- Spatially fractionated radiotherapy, stereotactic body radiotherapy, non small cell lung cancer, neoadjuvant chemoimmunotherapy
- 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.
Stereotactic body radiotherapy (SBRT)Radiation
spatially fractionated stereotactic body radiotherapy
neoadjuvant immunotherapyDrug
Toripalimab IV (dose 240mg) Q3W
Neoadjuvant ChemotherapyDrug
Squamous cell carcinoma: Paclitaxel (175mg/m²) or Docetaxel (60-75 mg/m²) or Nab-paclitaxel (260mg/m²) plus Carboplatin (AUC=5)/Cisplatin (75 mg/m²) (to be determined by researchers); Non-squamous cell carcinoma: Pemetrexed (500mg/m²) plus Carboplatin/Cisplatin (to be determined by researchers)
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy | Experimental | neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy Receives: Radiation: Stereotactic body radiotherapy (SBRT); Drug: neoadjuvant immunotherapy; Drug: Neoadjuvant Chemotherapy |
| toripalimab and platinum-based chemotherapy | Active comparator | toripalimab and platinum-based chemotherapy Receives: Drug: neoadjuvant immunotherapy; Drug: Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival rate
2-year event-free survival rate
Measured: 2-year event-free survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (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.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaping Xu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608159
- Sponsor's protocol ID
- L26-517
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase III Clinical Study of Spatially Fractionated Stereotactic Body Radiotherapy Plus Toripalimab and Chemotherapy Versus Toripalimab Plus Chemotherapy in Patients With Resectable or Potentially Resectable Stage II-III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07608159
- Acronym / sponsor ID
- L26-517
- Conditions
- Non Small Cell Lung Cancer, Stereotactic Body Radiotherapy, Neoadjuvant Chemoimmunotherapy, Surgery
- Keywords
- Spatially fractionated radiotherapy, stereotactic body radiotherapy, non small cell lung cancer, neoadjuvant chemoimmunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 27 May 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.
This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy | Experimental | Radiation: Stereotactic body radiotherapy (SBRT), Drug: neoadjuvant immunotherapy, Drug: Neoadjuvant Chemotherapyneoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy |
| toripalimab and platinum-based chemotherapy | Active comparator | Drug: neoadjuvant immunotherapy, Drug: Neoadjuvant Chemotherapytoripalimab and platinum-based chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants aged 18 to 75 years;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the 8th edition of the American Joint Committee on Cancer staging system;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1;
- Adequate pulmonary function, as assessed by the surgeon, to tolerate the planned lung resection;
Key exclusion criteria (25 listed)
- Locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the multidisciplinary consensus for stage III non-small cell lung cancer (2019 edition), including some stage IIIA, stage IIIB, and all stage IIIC disease. This usually includes N2 disease with a single-station mediastinal lymph node with a short-axis diameter ≥3 cm, or multistation lymph node fusion/conglomeration with lymph nodes having a short-axis diameter ≥2 cm on CT; T4 disease invading the esophagus, heart, aorta, or pulmonary veins; and all N3 disease;
- Non-small cell lung cancer involving the superior sulcus, large-cell neuroendocrine carcinoma, or sarcomatoid carcinoma;
- Known sensitizing EGFR mutation or ALK rearrangement. For participants with non-squamous histology, EGFR and ALK mutation status must be confirmed;
- Prior treatment with PD-1 or PD-L1 inhibitors, or agents targeting another T-cell receptor pathway, such as CTLA-4 or OX-40;
- Active or suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, and inflammatory bowel disease. Exceptions include type 1 diabetes mellitus or hypothyroidism controlled with stable replacement therapy, and dermatologic conditions not requiring systemic treatment, such as psoriasis or vitiligo;
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 |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)spatially fractionated stereotactic body radiotherapy | Radiation | neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy |
| neoadjuvant immunotherapyToripalimab IV (dose 240mg) Q3W | Drug | neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy, toripalimab and platinum-based chemotherapy |
| Neoadjuvant ChemotherapySquamous cell carcinoma: Paclitaxel (175mg/m²) or Docetaxel (60-75 mg/m²) or Nab-paclitaxel (260mg/m²) plus Carboplatin (AUC=5)/Cisplatin (75 mg/m²) (to be determined by researchers); Non-squamous cell carcinoma: Pemetrexed (500mg/m²) plus Carboplatin/Cisplatin (to be determined by researchers) | Drug | neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy, toripalimab and platinum-based chemotherapy |
Primary outcome
2-year event-free survival rate
Time frame: 2-year event-free survival rate
2-year event-free survival rate
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 29 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic body radiotherapy (SBRT), neoadjuvant immunotherapy and Neoadjuvant Chemotherapy in people with Non Small Cell Lung Cancer and Stereotactic Body Radiotherapy, run by Shanghai Pulmonary Hospital, Shanghai, 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 10 inclusion and 25 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 29 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Di Liu (+8617621320272, liudi_2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival rate (time frame: 2-year event-free survival rate). 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 29 May 2026.