Non-small Lung CancerPhase 2NCT06293690
Toripalimab Combined With SBRT for NSCLC
A Phase 2 study testing Toripalimab in people with Non-small Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Lung Cancer
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 30 Jun 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18 to 75 years old, regardless of gender;
- ECOG behavior status score 0-1 points;
- Non small cell lung cancer diagnosed pathologically and clinically classified as stage IIA-IIIB (8th AJCC staging standard);
- Sufficient tumor tissue can be provided for biomarker analysis;
- Patients with distant metastasis are excluded through CT or PET/CT, and their physical condition is evaluated as acceptable for radical lung cancer surgery;
- Primary lung lesions are suitable for SBRT treatment;
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- Confirming the absence of EGFR/ALK/ROS-1 sensitive gene mutations through molecular pathological diagnosis of the organization;
- The main organ functions within 7 days before the first administration meet the following standards:
- a Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment received within 14 days prior to platelet count test);b Coagulation function: INR and PT\<1.5 × ULN, APTT ≤ 1.5 × ULN;c Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in subjects with Gilbert\'s syndrome or liver metastasis) × ULN);d Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);e Adequate lung function: According to the doctor\'s judgment, lung function can meet the requirements of thymectomy surgery.
Who cannot join
- Pathological findings indicate complex small cell lung cancer, etc;
- History of previous lobectomy surgery and previous experience with radiotherapy and chemotherapy;
- Patients with concurrent secondary primary cancer and a history of malignant tumors less than 5 years (excluding completely cured cervical carcinoma in situ or basal or squamous cell skin cancer);
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- Have active infection or active tuberculosis history requiring systemic treatment;
- Those who have combined the following active infectious diseases, including those who are highly positive for hepatitis, known human immunodeficiency virus (HIV) infections, and sexually transmitted diseases such as active syphilis;
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- Those who are known to have or combine with other uncontrollable diseases and are unable to receive surgical treatment;
- Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients;
- Previous history of interstitial lung disease, drug-induced interstitial disease, or any clinically proven active interstitial lung disease, baseline CT scan reveals the presence of idiopathic pulmonary fibrosis; Uncontrolled large amounts of pleural or pericardial effusion;
- Unstable systemic comorbidities (active infection period, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction occurring within 6 months, severe mental disorders requiring drug control, metabolic diseases of the liver, kidney or other organs, neuropsychiatric disorders such as Alzheimer\'s disease);
- History of congenital or acquired immunodeficiency diseases or organ transplantation;
- Have received any of the following treatments:a Previously received chemotherapy, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or other drugs that synergistically inhibit T cell receptors such as CTLA-4, OX-40, and CD137; Received any investigational medication within 4 weeks prior to the first use of the investigational medication;b Simultaneously enroll in another clinical study, unless it is an observational (non-intervention) clinical study or an intervention clinical study follow-up;c Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug;d Having undergone major surgery or severe trauma within 4 weeks before the first use of the investigational drug;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Toripalimab Combined With SBRT in the Neoadjuvant Treatment for Operable or Potentially Operable Non-small Cell Lung Cancer in Stage IIA to IIIB
This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC
- Conditions
- Non-small Lung Cancer
- Being tested
- Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called SBRT, platinum-containing dual drugs
Patients received preoperative neoadjuvant therapy: SBRT 12gy on the first day, and Toripalimab (iv 240mg, q3W) combined with platinum-containing dual drugs on the second day. Two cycles in total.
ToripalimabDrug
Also called SBRT
Patients received preoperative neoadjuvant therapy: SBRT 12gy on the first day, and Toripalimab (iv 240mg, q3W) on the second day. Two cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| SBRT combined with immunochemotherapy | Other | A: Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3W) combined with platinum-containing dual drugs on the second day. Two cycles in total. Receives: Drug: Toripalimab |
| SBRT combined with immunotherapy | Other | B:Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3) on the second day. Two cycles in total. Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological remission rate
The percentage of residual live tumor cells in the tumor bed after neoadjuvant therapy is ≤ 10%, regardless of whether there are residual live tumor cells in the lymph nodes.
Measured: 30 day
Secondary outcomes (3)
Complete pathological remission rate
After a complete evaluation of excised lung cancer specimens, including lymph nodes in all sampling areas, there was a lack of any surviving tumor cells when re examining HE slides
Measured: 30 day
disease-free survival（DFS）
The time interval between receiving surgical treatment and tumor recurrence or death due to tumor progression
Measured: 3 years
overall survival
The time interval between receiving surgical treatment and the patient's death due to any reason, and the patient is still alive during the final follow-up, with the survival time ending at the last follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Apr 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293690
- Sponsor's protocol ID
- L23-407
- Status last verified
- Dec 2025
- First submitted
- 27 Feb 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Toripalimab Combined With SBRT in the Neoadjuvant Treatment for Operable or Potentially Operable Non-small Cell Lung Cancer in Stage IIA to IIIB
- ClinicalTrials.gov ID
- NCT06293690
- Acronym / sponsor ID
- L23-407
- Conditions
- Non-small Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Mar 2024 (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 aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT combined with immunochemotherapy | Other | Drug: ToripalimabA: Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3W) combined with platinum-containing dual drugs on the second day. Two cycles in total. |
| SBRT combined with immunotherapy | Other | Drug: ToripalimabB:Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3) on the second day. Two cycles in total. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age range from 18 to 75 years old, regardless of gender;
- ECOG behavior status score 0-1 points;
- Non small cell lung cancer diagnosed pathologically and clinically classified as stage IIA-IIIB (8th AJCC staging standard);
- Sufficient tumor tissue can be provided for biomarker analysis;
- Patients with distant metastasis are excluded through CT or PET/CT, and their physical condition is evaluated as acceptable for radical lung cancer surgery;
Key exclusion criteria (12 listed)
- Pathological findings indicate complex small cell lung cancer, etc;
- History of previous lobectomy surgery and previous experience with radiotherapy and chemotherapy;
- Patients with concurrent secondary primary cancer and a history of malignant tumors less than 5 years (excluding completely cured cervical carcinoma in situ or basal or squamous cell skin cancer);
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- Have active infection or active tuberculosis history requiring systemic treatment;
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 |
|---|---|---|
| ToripalimabAlso: SBRT, platinum-containing dual drugsPatients received preoperative neoadjuvant therapy: SBRT 12gy on the first day, and Toripalimab (iv 240mg, q3W) combined with platinum-containing dual drugs on the second day. Two cycles in total. | Drug | SBRT combined with immunochemotherapy |
| ToripalimabAlso: SBRTPatients received preoperative neoadjuvant therapy: SBRT 12gy on the first day, and Toripalimab (iv 240mg, q3W) on the second day. Two cycles in total. | Drug | SBRT combined with immunotherapy |
Primary outcome
Major pathological remission rate
Time frame: 30 day
The percentage of residual live tumor cells in the tumor bed after neoadjuvant therapy is ≤ 10%, regardless of whether there are residual live tumor cells in the lymph nodes.
3 secondary outcomes
Complete pathological remission rate
Time frame: 30 day
disease-free survival（DFS）
Time frame: 3 years
overall survival
Time frame: 3 years
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 18 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab in people with Non-small Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 9 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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.
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?
Major pathological remission rate (time frame: 30 day). 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 18 Dec 2025.