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New treatment option for Locally Advanced Non-Small Cell Lung Cancer
Official title Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC
ClinicalTrials.gov ID: NCT07309952
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Surgical Feasibility: The lung lesion is considered \ \ potentially resectable as evaluated by a multidisciplinary team that includes a thoracic...
- 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...
You likely can't join if
- Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring...
- Immunosuppressive Therapy: Requires systemic corticosteroid therapy (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications...
- 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...
- Poorly Controlled Diabetes: History of diabetes mellitus for \>10 years with unsatisfactory glycemic control.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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...
- 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: (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). 13\. HIV/AIDS...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.