Neoadjuvant ImmunotherapyPhase 2NCT07231575
Neoadjuvant SBRT and Tislelizumab (Immunotherapy) Plus Anlotinib for Resectable EGFR Wild-type NSCLC
A Phase 2 study testing SBRT, Immunotherapy and antiangiogenesis therapy in people with Neoadjuvant Immunotherapy and NSCLC, run by Sun Yat-sen University.
Trial summary
The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoadjuvant Immunotherapy, NSCLC, Chemo-free Therapy
- What is being tested?
- SBRT, Immunotherapy and antiangiogenesis therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2025to 30 May 2032
- 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
- 1.18 years or older 2. Eastern Cooperative Oncology Group performance status: 0 or 1 3. Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC 4. Adequate cardiopulmonary and haematological function.
Who cannot join
- Known EGFR-sensitising mutations and EML4-ALK fusions
- Concomitant malignancy, history of another cancer within the past 3 years.
- Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan
About this study
Official title: Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）
The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.
- Conditions
- Neoadjuvant Immunotherapy, NSCLC, Chemo-free Therapy
- Being tested
- SBRT, Immunotherapy, antiangiogenesis therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT 8Gy*3
ImmunotherapyDrug
Tislelizumab (immunotherapy) 200mg Q3W
antiangiogenesis therapyDrug
Anlotinib 8mg D1-D14 Q3W
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib | Experimental | Not described Receives: Radiation: SBRT; Drug: Immunotherapy; Drug: antiangiogenesis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response(pCR, rate)
Measured: At the time of surgery
Secondary outcomes (1)
Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month）
Measured: Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua Fu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231575
- Sponsor's protocol ID
- STATION
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 18 Nov 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）
- ClinicalTrials.gov ID
- NCT07231575
- Acronym / sponsor ID
- STATION
- Conditions
- Neoadjuvant Immunotherapy, NSCLC, Chemo-free Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2032 (estimated)
- First posted
- 17 Nov 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.
The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib | Experimental | Radiation: SBRT, Drug: Immunotherapy, Drug: antiangiogenesis therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 years or older 2. Eastern Cooperative Oncology Group performance status: 0 or 1 3. Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC 4. Adequate cardiopulmonary and haematological function.
Key exclusion criteria (3 listed)
- Known EGFR-sensitising mutations and EML4-ALK fusions
- Concomitant malignancy, history of another cancer within the past 3 years.
- Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan
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 |
|---|---|---|
| SBRTSBRT 8Gy*3 | Radiation | Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib |
| ImmunotherapyTislelizumab (immunotherapy) 200mg Q3W | Drug | Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib |
| antiangiogenesis therapyAnlotinib 8mg D1-D14 Q3W | Drug | Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib |
Primary outcome
Pathologic Complete Response(pCR, rate)
Time frame: At the time of surgery
1 secondary outcome
Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month）
Time frame: Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event
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 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT, Immunotherapy and antiangiogenesis therapy in people with Neoadjuvant Immunotherapy and NSCLC, run by Sun Yat-sen 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 1 inclusion and 3 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 18 Nov 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.
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?
Pathologic Complete Response(pCR, rate) (time frame: At the time of surgery). 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 Nov 2025.