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.
The subject is able to understand the informed consent form, voluntarily participate in the study, and has signed the informed consent form.
The subject is ≥18 years and ≤80 years of age on the day of signing the informed consent form; both males and females are eligible.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC), according to the AJCC 9th edition TNM staging system for lung cancer.
Histopathological evidence of any small cell carcinoma component, or diagnosis of large cell neuroendocrine carcinoma or sarcomatoid carcinoma.
Presence of another malignancy within 3 years prior to the first dose, except for tumors that have been clinically cured by local treatment and have an extremely low risk of recurrence (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix, localized prostate cancer, etc.), or tumors with disease-free survival ≥ 3 years after curative treatment and an extremely low risk of recurrence or metastasis (e.g., ductal carcinoma in situ after radical surgery, papillary thyroid carcinoma after radical surgery, etc.).
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;
Single group
JSKN016 + Toripalimab + Carboplatin
DrugDuring the neoadjuvant treatment phase, enrolled subjects will receive combination therapy with JSKN016 (4 mg/kg) + toripalimab (240 mg) + carboplatin (AUC 5) in 3-week cycles, with a maximum of 4 cycles. Subjects meeting surgical criteria will undergo surgery within 8 weeks after the last neoadjuvant treatment cycle. A preoperative visit will be conducted 1 week (±1 week) prior to surgery. Surgery may be advanced if the investigator determines the subject is stable and fit for surgery, provided it occurs at least 7 days after the last study drug administration. Resected tumor specimens will undergo assessment of surgical margins and extent of resection (R0, R1/R2). Tumor tissue will be evaluated for pathological response (MPR and pCR). Subsequent adjuvant therapy will follow standard clinical practice.
Pathological Complete Response (PCR) Rate
PCR is defined as the absence of any viable tumor cells in the primary tumor site and all sampled lymph node regions of the resected specimen after neoadjuvant therapy, as confirmed by complete pathological assessment.
Major Pathological Response (MPR) Rate
MPR is defined as the proportion of viable tumor cells in the resected primary tumor site after neoadjuvant therapy being ≤ 10%.
Event-Free Survival (EFS)
Overall survival (OS)
Disease Control Rate(DCR)
Disease Control Rate (DCR) refers to the proportion of patients whose tumors or diseases achieve "Complete Response (CR)," "Partial Response (PR)," or "Stable Disease (SD)" (according to RECIST1.1) after receiving drug treatment
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
