Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy fo… (NCT07554846) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC
China759 participantsStarted 2026-05-01
Plain-language summary
This is a randomized, open-label, multi-center Phase III clinical study aimed at head-to-head evaluating the clinical efficacy of three immunotherapy strategies, namely perioperative immunotherapy, neoadjuvant immunotherapy, and adjuvant immunotherapy using Toripalimab, in patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC) without EGFR/ALK mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18-75, of either gender;
✓. Subjects with resectable stage II-IIIA non-small cell lung cancer (according to the AJCC 8th edition), EGFR wild type, and no ALK rearrangement, confirmed by histology or pathology;
✓. ECOG PS score of 0-1;
✓. There are measurable lesions according to RECIST 1.1;
✓. Expected survival duration ≥ 3 months;
✓. Main organ functions are normal (14 days before enrollment)
✓. According to the surgeon's assessment, the total lung function is capable of withstanding the proposed lung resection surgery;
Exclusion criteria
✕. Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
✕. Currently participating in and receiving other research treatments;
✕. Previously received systemic treatment for resectable stage II-III non-small cell lung cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc;
✕. Patients with active tuberculosis (TB) who are currently undergoing anti-tuberculosis treatment or have received such treatment within the previous 1 year prior to screening;
✕. Uncontrollable or symptomatic hypercalcemia (\>1.5 mmol/L calcium ion or calcium \>12 mg/dL or corrected serum calcium \>ULN);
What they're measuring
1
3-year events-free survival (EFS) rate
Timeframe: From randomization up to 3 years after randomization
✕. Clinically, there is uncontrolled active infection, including but not limited to acute pneumonia;
✕. Uncontrollable severe epileptic seizures or superior vena cava syndrome;
✕. Previously or currently suffering from other malignant tumors (excluding non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder cancer, and other carcinoma in situ that have undergone radical treatment with no evidence of disease recurrence);