Triple-threat treatment aims to make inoperable lung cancer removable
NCT ID NCT07309952
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase II trial tests whether giving a short course of radiation, followed by two cycles of immunotherapy (sintilimab) plus chemotherapy, can shrink advanced lung cancer that has spread to lymph nodes on the opposite side of the chest. The goal is to make the cancer operable and improve long-term outcomes. The study enrolls 28 adults aged 18–75 with previously untreated stage IIIB or IIIC non-small cell lung cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab (immunotherapy), paclitaxel or nab-paclitaxel (chemotherapy), and stereotactic body radiotherapy (radiation)
- What this could lead to
- If successful, this approach could help shrink tumors enough to allow surgery in patients with advanced lung cancer, potentially improving survival and reducing recurrence.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. The combination of radiation, immunotherapy, and chemotherapy can cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary Participation: The patient volunteers to participate and signs a written informed consent form. 2. 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. 3. Surgical Feasibility: The lung lesion is considered \*\*potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. 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. 6\. Age: Between 18 and 75 years old. Exclusion Criteria 1. 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. 2. Immunosuppressive Therapy: Requires systemic corticosteroid therapy (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment. 3. Prior Chest Radiotherapy: History of prior radiotherapy to the chest. 4. Active Bleeding: Presence of clinically significant active bleeding prior to treatment. 5. 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. 6. Poorly Controlled Diabetes: History of diabetes mellitus for \>10 years with unsatisfactory glycemic control. 7. Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis. 8. Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity. 9. 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. 10. 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. 11. 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. 12. 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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