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Taking people in ChinaPhase 2

Radiation, then sintilimab with chemotherapy, for lung cancer that spread to opposite-side lymph nodes

Tests radiation then sintilimab with chemotherapy before surgery in advanced non-small cell lung cancer.

Key facts

Who runs it
Yang Hong
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
Status
Recruiting
Phase
Phase 2
People taking part
28 people, planned
Started
31 Dec 2025
Expected to end
31 Oct 2032
Type of study
Interventional
Treatments tested
  • Sintilimab
  • Paclitaxel
  • Carboplatin (AUC 5)
  • Pemetrexed 500 mg/m2
  • Stereotactic body radiotherapy (SBRT)
  • non-small cell lung cancer
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-small cell lung cancer that has spread to lymph nodes in the middle of the chest on the opposite side (N3), has had no treatment yet, and may be removable by surgery.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Stage IIIB or IIIC non-small cell lung cancer with N3 lymph node spread on the opposite side of the chest. The lung tumour must be possibly removable by surgery. ECOG performance status 0 or 1.
Earlier treatment
No earlier treatment for this cancer. Cannot have had earlier chest radiotherapy or earlier anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 treatment.
Biomarker or test result
Cannot join with known activating EGFR mutations or ALK fusion gene positivity.

Main reasons for not taking part

  • Active or suspected autoimmune disease (with a few listed exceptions)
  • Spread to the lymph nodes above the collarbone or to distant organs
  • Known HIV infection or AIDS
  • Interstitial lung disease or non-infectious pneumonitis
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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:; (1) 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
  • Age: Between 18 and 75 years old

Who cannot take part

  • 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
  • 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
  • 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
  • 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
  • Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis
  • 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
  • Active Viral Infection:; (1) Active Hepatitis B (HBsAg positive AND HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL); (2) Active Hepatitis C (HCV antibody positive AND HCV RNA above the lower limit of detection)
  • HIV/AIDS: Known positive test for human immunodeficiency virus (HIV) or diagnosed acquired immunodeficiency syndrome (AIDS)
  • Allergy: Known history of hypersensitivity to sintilimab, any of the chemotherapy agents used, or any of their excipients
  • Pregnancy/Lactation: Pregnant or breastfeeding women. 16. Metastatic Disease: Presence of supraclavicular lymph node metastasis or distant metastasis
  • Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity
  • Poorly Controlled Diabetes: History of diabetes mellitus for >10 years with unsatisfactory glycemic control
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Hong Prof. Yang, M.D., PH.D.Taking people

About the trial

What the trial wants to find out

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 full original descriptionShow less

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.

The group in the trial

  • Experimental : neoadjuvant SBRT combined with immunochemotherapyTreatment being tested

    Treatment: Sintilimab, Paclitaxel, Carboplatin (AUC 5), Pemetrexed 500 mg/m2, Stereotactic body radiotherapy (SBRT), and non-small cell lung cancer

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Radiation, then sintilimab with chemotherapy, for lung cancer that spread to opposite-side lymph nodesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07309952, who can take part
Record updated
30 April 2026