The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Smal… (NCT05798845) | Clinical Trial Compass
RecruitingPhase 2
The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer
China124 participantsStarted 2025-02-20
Plain-language summary
This randomized phase II trial is to explore the clinical efficacy, safety and feasibility of neoadjuvant immunotherapy plus radiotherapy compared with neoadjuvant immunotherapy plus chemotherapy in operable stage II-IIIA (N+) non small cell lung cancer (NSCLC) and the optimal radiotherapy pattern.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 to 75 years old, gender is not limited.
✓. ECOG performance status 0-1.
✓. non-small cell lung cancer diagnosed by pathology.
✓. sufficient tumor tissue available for biomarker analysis.
✓. clinical staging of cT1-2N1-2M0 or T3N1M0, stage II-IIIA (8th UICC staging criteria).
✓. Patients with distant metastases ruled out by CT or PET/CT and physically assessed as acceptable for radical lung cancer surgery.
✓. histomolecular pathology confirming the absence of classic driver oncogene mutations in EGFR, ALK, or ROS1.
✓. Basic normal function of all organs (laboratory test results within 1 week prior to enrollment).
Exclusion criteria
✕. Pathology suggestive of compound small cell lung cancer, etc.
✕. History of previous lobectomy, radiotherapy or chemotherapy.
✕. Those with concurrent second primary carcinoma and a history of previous malignancy of less than 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous epithelial cell skin cancer).
✕. Patients with any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.).
✕. Have an active infection requiring systemic treatment or a history of active tuberculosis.
✕. Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
✕. Those with known presence or coexistence of other uncontrollable diseases that are not amenable to surgical treatment
✕. Physical examination or clinical trial finds that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk for treatment complications