Actively Recruiting
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
Led by Yang Hong · Updated on 2026-04-30
28
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 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. This Phase II clinical trial focuses on patients aged 18 to 75 years with untreated, potentially resectable stage IIIB-IIIC NSCLC. The study aims to assess whether the treatment can reduce cancer in the contralateral mediastinal lymph node and increase the chance for curative surgery, while also monitoring safety and other outcomes. The treatment plan involves stereotactic body radiation therapy (SBRT) targeting the primary lung tumor in three sessions over about three days. Within a week after SBRT, participants receive two cycles of sintilimab, an immunotherapy drug, combined with platinum-based chemotherapy. Depending on cancer type, chemotherapy drugs include paclitaxel or pemetrexed, along with carboplatin. After neoadjuvant therapy, patients undergo cervical mediastinoscopy to assess lymph nodes; those with negative results proceed to surgery involving lung resection and lymph node removal. During the study, patients will be closely monitored through about 12 weeks of treatment and surgical assessment, followed by follow-up visits lasting up to five years after surgery. Researchers will evaluate outcomes such as lymph node downstaging, surgical success, pathological response, survival rates, and adverse events. The study includes various assessments like imaging scans, pathology reviews, and safety monitoring to track treatment effects and patient health over time.
CONDITIONS
Brief Title
Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient volunteers and provides written informed consent
- Confirmed untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), stage IIIB or IIIC
- 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 including specified blood counts, kidney, liver, and lung function
- Age between 18 and 75 years old
You will not qualify if you...
- Active or suspected autoimmune disease (except controlled vitiligo, type I diabetes, or hypothyroidism requiring only hormone replacement)
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before enrollment
- Prior radiotherapy to the chest
- Clinically significant active bleeding before treatment
- Severe organ dysfunction or cachexia intolerable to chemo-radiotherapy
- Poorly controlled diabetes for more than 10 years
- History of interstitial lung disease or non-infectious pneumonitis
- NSCLC with known EGFR mutations or ALK gene fusion
- Other active malignancies within past 2 years except certain treated cancers; exceptions for remission over 2 years
- Conditions preventing study completion or understanding
- Previous treatment with immune checkpoint inhibitors
- Active hepatitis B or C infection
- HIV/AIDS diagnosis
- Known allergies to sintilimab or chemotherapy agents
- Pregnant or breastfeeding women
- Presence of supraclavicular or distant metastasis
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 days
Participants receive stereotactic body radiotherapy (SBRT) directed at the primary lung tumor before starting systemic therapy.
3 treatment sessions over 3 days
Duration - Approximately 6 weeks
Participants receive 2 cycles of neoadjuvant therapy combining sintilimab with platinum-based doublet chemotherapy (paclitaxel or pemetrexed plus carboplatin) starting within 7 days after SBRT completion.
2 treatment cycles with infusions on Day 1 of each 3-week cycle
Duration - Approximately 6 weeks from the start of surgery assessment to post-surgical recovery
Approximately 4 weeks after neoadjuvant therapy, participants undergo cervical mediastinoscopy for lymph node assessment followed by radical lung resection if eligible.
1 mediastinoscopy visit and 1 surgery with immediate post-operative care
Duration - Up to 5 years
Participants are monitored after surgery to assess outcomes such as event-free survival and overall survival.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang
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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