Locally Advanced Non-Small Cell Lung CancerPhase 2SACTION 2501NCT07309952
Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
A Phase 2 study testing Sintilimab, Paclitaxel and Carboplatin (AUC 5) in people with Locally Advanced Non-Small Cell Lung Cancer and Stage IIIb Non-small Cell Lung Cancer, run by Yang Hong at 1 site in China.
Trial summary
This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer, Stage IIIb Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
- What is being tested?
- Sintilimab, Paclitaxel and Carboplatin (AUC 5)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary Participation: The patient volunteers to participate and signs a written informed consent form.
- Pathology and Staging: Cytologically or histologically confirmed, previously untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), classified as stage IIIB or IIIC according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging manual. Baseline staging must be performed with either PET/CT or a combination of contrast-enhanced CT of chest/abdomen + bone scan + brain MRI.
- Surgical Feasibility: The lung lesion is considered **potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate Organ Function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (2) Platelet count ≥ 100 x 10^9/L (3) Hemoglobin > 9.0 g/dL (4) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL/min (5) Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 3 x ULN (6) Total bilirubin ≤ 1.5 x ULN (7) Forced expiratory volume in 1 second (FEV1) ≥ 1.2 L or > 40% of predicted value (8) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal limits.
- 6. Age: Between 18 and 75 years old.
Who cannot join
- Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring only hormone replacement therapy (e.g., Hashimoto's thyroiditis) with no signs of active disease may be enrolled.
- Immunosuppressive Therapy: Requires systemic corticosteroid therapy (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment.
- Prior Chest Radiotherapy: History of prior radiotherapy to the chest.
- Active Bleeding: Presence of clinically significant active bleeding prior to treatment.
- Severe Organ Dysfunction: Severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system disease, or cachexia, as judged by the investigator to be intolerable to chemo-radiotherapy.
- Poorly Controlled Diabetes: History of diabetes mellitus for >10 years with unsatisfactory glycemic control.
Show all 19Show fewer
- Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis.
- Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity.
- Other Malignancies:
- Excluded: History of other active malignancies within the past 2 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast).
- Exception: Patients with other malignancies who have achieved complete remission for ≥2 years and do not require additional anti-tumor therapy during this study may be enrolled.
- Compliance/Understanding: Medical, psychological, or physiological conditions that, in the investigator's judgment, prevent the patient from completing the study or understanding the study information.
- Prior Immune Therapy: Previous treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other drug targeting T-cell co-stimulation or checkpoint pathways.
- Active Viral Infection:
- Active Hepatitis B (HBsAg positive AND HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL).
- Active Hepatitis C (HCV antibody positive AND HCV RNA above the lower limit of detection).
- 13. HIV/AIDS: Known positive test for human immunodeficiency virus (HIV) or diagnosed acquired immunodeficiency syndrome (AIDS).
- 14. Allergy: Known history of hypersensitivity to sintilimab, any of the chemotherapy agents used, or any of their excipients.
- 15. Pregnancy/Lactation: Pregnant or breastfeeding women. 16. Metastatic Disease: Presence of supraclavicular lymph node metastasis or distant metastasis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hong Prof. Yang, M.D., PH.D., 86+02087340973, yanghong@sysucc.org.cn
About this study
Official title: Neoadjuvant Stereotactic Body Radiotherapy Followed by Sintilimab Plus Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer With Contralateral Mediastinal (N3) Lymph Node Metastasis: A Prospective Phase II Clinical Trial
This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement).
The study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery.
Read more
The main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety.
Patients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer, Stage IIIb Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
- Being tested
- Sintilimab, Paclitaxel, Carboplatin (AUC 5), Pemetrexed 500 mg/m2, Stereotactic body radiotherapy (SBRT)
- 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.
SintilimabDrug
Sintilimab is an anti-PD-1 monoclonal antibody. In this study, it is administered intravenously at a fixed dose of 200 mg on Day 1 of each 3-week cycle. Patients receive 2 cycles of sintilimab in combination with platinum-based doublet chemotherapy. The first dose of sintilimab is initiated within 7 days after completion of stereotactic body radiotherapy (SBRT).
PaclitaxelDrug
Paclitaxel is a taxane chemotherapeutic agent. In this study, it is specifically used for patients with squamous cell non-small cell lung cancer (NSCLC). It is administered intravenously at a dose of 175 mg/m² on Day 1 of each 3-week cycle. Patients receive 2 cycles of paclitaxel in combination with sintilimab (anti-PD-1 antibody) and carboplatin (platinum-based agent) as part of the neoadjuvant regimen. Standard premedication to prevent hypersensitivity reactions is required prior to each infusion. This systemic chemotherapy phase is initiated within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor.
Carboplatin (AUC 5)Drug
Carboplatin is a platinum-based chemotherapeutic agent. In this study, it serves as the backbone chemotherapy for all patients, regardless of histology. It is administered intravenously on Day 1 of each 3-week cycle. The dose is calculated using the Calvert formula to achieve a target area under the concentration-time curve (AUC) of 5 mg/mL/min. Patients receive 2 cycles of carboplatin in combination with sintilimab (anti-PD-1 antibody) and either pemetrexed (for non-squamous NSCLC) or paclitaxel (for squamous NSCLC). This chemoinmunotherapy phase commences within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor.
Pemetrexed 500 mg/m2Drug
Pemetrexed is an antifolate chemotherapeutic agent. In this study, it is specifically used for patients with non-squamous non-small cell lung cancer (NSCLC). It is administered intravenously at a dose of 500 mg/m² on Day 1 of each 3-week cycle. Patients receive 2 cycles of pemetrexed in combination with sintilimab (anti-PD-1 antibody) and carboplatin (platinum-based agent) as part of the neoadjuvant regimen. To reduce toxicity risks, standard premedication (including folic acid, vitamin B12 supplementation, and corticosteroids) is required as per the product label. This systemic chemotherapy phase is initiated within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor.
Stereotactic body radiotherapy (SBRT)Radiation
Stereotactic Body Radiotherapy (SBRT) is a precise, high-dose form of external beam radiation therapy. In this study, SBRT is directed only at the primary lung tumor (not the lymph nodes). The treatment is delivered in 3 fractions (sessions) over approximately 3 days, with a total dose of 24 Gy (8 Gy per fraction). Treatment planning is based on 4D-CT simulation to account for respiratory motion. The SBRT is completed before the initiation of systemic therapy (sintilimab + chemotherapy).
non-small cell lung cancerProcedure or surgery
Radical lung resection is the planned definitive treatment for eligible patients. Approximately 4 weeks after neoadjuvant therapy, patients first undergo cervical mediastinoscopy for contralateral lymph node assessment. Only those with negative pathology proceed to surgery 2 weeks later. The surgery involves initial video-assisted thoracoscopic dissection of remaining contralateral nodes (specific stations based on primary tumor side) with intraoperative frozen section. If negative, patients undergo immediate repositioning and radical lung resection (lobectomy/pneumonectomy) with ipsilateral lymphadenectomy(right side dissection of lymph nodes in groups 3A, 9R and 10R, left side dissection of lymph nodes in groups 5, 6, 9L and 10L).
| Study group | Role | What they receive |
|---|---|---|
| Experimental : neoadjuvant SBRT combined with immunochemotherapy | Experimental | Not described Receives: Drug: Sintilimab; Drug: Paclitaxel; Drug: Carboplatin (AUC 5); Drug: Pemetrexed 500 mg/m2; Radiation: Stereotactic body radiotherapy (SBRT); Procedure: non-small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral Mediastinal Lymph Node Downstaging Rate
Measured: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
Surgical Conversion Rate
Measured: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
Secondary outcomes (6)
Major Pathological Response Rate
Measured: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
Pathological Complete Response Rate
Measured: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
R0 Resection Rate
Measured: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
Event-Free Survival
Measured: From enrollment until the first occurrence of an EFS event, assessed up to 5 years.
Overall Survival
Measured: From enrollment until death from any cause, assessed up to 5 years.
Incidence of Adverse Events
Measured: From the start of neoadjuvant therapy until 90 days after the last dose of study drug or 30 days after surgery, whichever is later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start31 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Hong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309952
- Sponsor's protocol ID
- B2025-696-01
- Acronym
- SACTION 2501
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 30 Apr 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Stereotactic Body Radiotherapy Followed by Sintilimab Plus Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer With Contralateral Mediastinal (N3) Lymph Node Metastasis: A Prospective Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07309952
- Acronym / sponsor ID
- SACTION 2501 / B2025-696-01
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer, Stage IIIb Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Yang HongUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 30 Dec 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 is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement).
The study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery.
The main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety.
Patients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental : neoadjuvant SBRT combined with immunochemotherapy | Experimental | Drug: Sintilimab, Drug: Paclitaxel, Drug: Carboplatin (AUC 5), Drug: Pemetrexed 500 mg/m2, Radiation: Stereotactic body radiotherapy (SBRT), Procedure: non-small cell lung cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary Participation: The patient volunteers to participate and signs a written informed consent form.
- Pathology and Staging: Cytologically or histologically confirmed, previously untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), classified as stage IIIB or IIIC according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging manual. Baseline staging must be performed with either PET/CT or a combination of contrast-enhanced CT of chest/abdomen + bone scan + brain MRI.
- Surgical Feasibility: The lung lesion is considered **potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate Organ Function:
Key exclusion criteria (19 listed)
- Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring only hormone replacement therapy (e.g., Hashimoto's thyroiditis) with no signs of active disease may be enrolled.
- Immunosuppressive Therapy: Requires systemic corticosteroid therapy (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment.
- Prior Chest Radiotherapy: History of prior radiotherapy to the chest.
- Active Bleeding: Presence of clinically significant active bleeding prior to treatment.
- Severe Organ Dysfunction: Severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system disease, or cachexia, as judged by the investigator to be intolerable to chemo-radiotherapy.
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 |
|---|---|---|
| SintilimabSintilimab is an anti-PD-1 monoclonal antibody. In this study, it is administered intravenously at a fixed dose of 200 mg on Day 1 of each 3-week cycle. Patients receive 2 cycles of sintilimab in combination with platinum-based doublet chemotherapy. The first dose of sintilimab is initiated within 7 days after completion of stereotactic body radiotherapy (SBRT). | Drug | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
| PaclitaxelPaclitaxel is a taxane chemotherapeutic agent. In this study, it is specifically used for patients with squamous cell non-small cell lung cancer (NSCLC). It is administered intravenously at a dose of 175 mg/m² on Day 1 of each 3-week cycle. Patients receive 2 cycles of paclitaxel in combination with sintilimab (anti-PD-1 antibody) and carboplatin (platinum-based agent) as part of the neoadjuvant regimen. Standard premedication to prevent hypersensitivity reactions is required prior to each infusion. This systemic chemotherapy phase is initiated within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor. | Drug | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
| Carboplatin (AUC 5)Carboplatin is a platinum-based chemotherapeutic agent. In this study, it serves as the backbone chemotherapy for all patients, regardless of histology. It is administered intravenously on Day 1 of each 3-week cycle. The dose is calculated using the Calvert formula to achieve a target area under the concentration-time curve (AUC) of 5 mg/mL/min. Patients receive 2 cycles of carboplatin in combination with sintilimab (anti-PD-1 antibody) and either pemetrexed (for non-squamous NSCLC) or paclitaxel (for squamous NSCLC). This chemoinmunotherapy phase commences within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor. | Drug | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
| Pemetrexed 500 mg/m2Pemetrexed is an antifolate chemotherapeutic agent. In this study, it is specifically used for patients with non-squamous non-small cell lung cancer (NSCLC). It is administered intravenously at a dose of 500 mg/m² on Day 1 of each 3-week cycle. Patients receive 2 cycles of pemetrexed in combination with sintilimab (anti-PD-1 antibody) and carboplatin (platinum-based agent) as part of the neoadjuvant regimen. To reduce toxicity risks, standard premedication (including folic acid, vitamin B12 supplementation, and corticosteroids) is required as per the product label. This systemic chemotherapy phase is initiated within 7 days after the completion of stereotactic body radiotherapy (SBRT) to the primary lung tumor. | Drug | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
| Stereotactic body radiotherapy (SBRT)Stereotactic Body Radiotherapy (SBRT) is a precise, high-dose form of external beam radiation therapy. In this study, SBRT is directed only at the primary lung tumor (not the lymph nodes). The treatment is delivered in 3 fractions (sessions) over approximately 3 days, with a total dose of 24 Gy (8 Gy per fraction). Treatment planning is based on 4D-CT simulation to account for respiratory motion. The SBRT is completed before the initiation of systemic therapy (sintilimab + chemotherapy). | Radiation | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
| non-small cell lung cancerRadical lung resection is the planned definitive treatment for eligible patients. Approximately 4 weeks after neoadjuvant therapy, patients first undergo cervical mediastinoscopy for contralateral lymph node assessment. Only those with negative pathology proceed to surgery 2 weeks later. The surgery involves initial video-assisted thoracoscopic dissection of remaining contralateral nodes (specific stations based on primary tumor side) with intraoperative frozen section. If negative, patients undergo immediate repositioning and radical lung resection (lobectomy/pneumonectomy) with ipsilateral lymphadenectomy(right side dissection of lymph nodes in groups 3A, 9R and 10R, left side dissection of lymph nodes in groups 5, 6, 9L and 10L). | Procedure or surgery | Experimental : neoadjuvant SBRT combined with immunochemotherapy |
Primary outcome
Contralateral Mediastinal Lymph Node Downstaging Rate
Time frame: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
Surgical Conversion Rate
Time frame: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
6 secondary outcomes
Major Pathological Response Rate
Time frame: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
Pathological Complete Response Rate
Time frame: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
R0 Resection Rate
Time frame: At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.
Event-Free Survival
Time frame: From enrollment until the first occurrence of an EFS event, assessed up to 5 years.
Overall Survival
Time frame: From enrollment until death from any cause, assessed up to 5 years.
Incidence of Adverse Events
Time frame: From the start of neoadjuvant therapy until 90 days after the last dose of study drug or 30 days after surgery, whichever is later.
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 30 Apr 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.
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 Sintilimab, Paclitaxel and Carboplatin (AUC 5) in people with Locally Advanced Non-Small Cell Lung Cancer and Stage IIIb Non-small Cell Lung Cancer, run by Yang Hong 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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
Contact Hong Yang (86+020-87340973, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contralateral Mediastinal Lymph Node Downstaging Rate (time frame: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.). The study lists 2 primary outcomes in all. 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 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.