Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (SCIENCE Study)

1. Anticipated inability to tolerate an anatomical lobectomy;

2. Anticipated requirement for sleeve resection, pneumonectomy, or pulmonary autotransplantation to remove the affected lobe;

3. Prior thoracic radiotherapy before the initiation of surgical treatment;

4. History of allogeneic tissue or solid organ transplantation;

5. Diagnosis of an autoimmune disease within 3 months prior to surgery, or currently receiving long-term systemic corticosteroid therapy (at a dose \>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy;

6. History of or current non-infectious interstitial lung disease requiring corticosteroid therapy;

7. Presence of viral infectious diseases during the screening period:

1. Seropositivity for human immunodeficiency virus (HIV);

2. Active hepatitis B: positive for hepatitis B surface antigen (HBsAg) with an HBV-DNA viral load \>500 IU/mL or \>2000 copies/mL;

3. Active hepatitis C: positive for hepatitis C virus (HCV) antibody with an HCV-RNA viral load above the upper limit of normal (ULN);

8. Poorly controlled hypertension despite medical therapy, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg (adjustment of antihypertensive medications is permitted prior to study initiation, provided that the average of the last three consecutive blood pressure readings taken prior to enrollment is ≤150/90 mmHg, with at least a 2-minute interval between each measurement);

9. Active infection requiring intravenous anti-infective therapy at the time of screening;

10. History of another malignancy within 3 years prior to providing informed consent, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, superficial bladder cancer, and localized prostate cancer. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, PSA \<10 ng/mL) are eligible to enroll if they have received radical treatment or are under active surveillance with stable disease, regardless of prior treatment status;

11. Any condition that, in the investigator's judgment, might interfere with the interpretation of study results, compromise the participant's ability to complete the study, or render study participation contrary to the participant's best interests;

12. Pregnant, lactating, or planning to become pregnant; or having a positive serum pregnancy test within 7 days prior to the first study treatment;

13. Poor compliance, or unwilling or unable to adhere to the protocol-specified procedures.

What this study is about