Actively Recruiting
Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
Led by Yang Hong · Updated on 2026-04-30
28
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees to participate and signs informed consent.
- Diagnosed with untreated non-small cell lung cancer with contralateral mediastinal lymph node involvement (N3), stage IIIB or IIIC.
- Cancer staging performed by PET/CT or combined contrast-enhanced CT of chest/abdomen, bone scan, and brain MRI.
- Lung tumor considered potentially removable by surgery as evaluated by a multidisciplinary team.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as shown by blood counts, kidney and liver tests, lung function (FEV1 ≥ 1.2 L or >40% predicted), and normal blood clotting tests.
- Age between 18 and 75 years old.
You will not qualify if you...
- Active or suspected autoimmune disease, except vitiligo, type I diabetes, or hypothyroidism managed with hormone therapy.
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before enrollment.
- Previous radiotherapy to the chest.
- Clinically significant active bleeding.
- Severe heart, lung, liver, kidney problems, blood disorders, or cachexia preventing chemo-radiotherapy.
- Poorly controlled diabetes lasting more than 10 years.
- History of interstitial lung disease or non-infectious pneumonitis.
- NSCLC with known activating EGFR mutations or ALK gene fusion.
- History of other active cancers within 2 years, except treated non-melanoma skin cancer or carcinoma in situ; exceptions for cancers in remission ≥2 years.
- Conditions preventing study completion or understanding.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar immune checkpoint drugs.
- Active hepatitis B or C infection.
- Known HIV infection or AIDS.
- Allergy to sintilimab, chemotherapy agents used, or their components.
- Pregnant or breastfeeding women.
- Presence of supraclavicular lymph node metastasis or distant metastasis.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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