Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non… (NCT07493980) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients
China54 participantsStarted 2026-03
Plain-language summary
This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Bone marrow function (no transfusion of whole blood or blood components within 14 days before the first dose; no hematopoietic growth factors within 7 days before the first dose):
✓. Liver function:
✓. Renal function:
✓. Coagulation function:
✓. Cardiac function:
✓. Pulmonary function:
Exclusion criteria
✕. Use of any investigational drug within 28 days prior to the first dose;
✕. Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose;
✕. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose;
✕. Requirement for systemic glucocorticoids (\>10 mg/day prednisone or equivalent doses of other glucocorticoids) for more than 7 consecutive days, or immunosuppressive therapy, within 14 days prior to the first dose.
✕. Major surgery (e.g., abdominal or thoracic surgery) within 28 days prior to the first dose, excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement, or anticipated need for major surgery during the study period;
What they're measuring
1
Pathological Complete Response (PCR) Rate
Timeframe: About 5 months after enrollment
Trial details
NCT IDNCT07493980
SponsorShanghai Pulmonary Hospital, Shanghai, China