This study targets patients with in first-line treatment of advanced NSCLC, enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Pemetrexed (500 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1) + pemetrexed (500 mg/m2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Paclitaxel (175 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
JS207 (10 mg/kg or 15 mg/kg, IV, d1)
Pemetrexed (500 mg/m2 IV, D1)
Platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1)
Paclitaxel (175 mg/m2 IV, D1)
Shandong First Medical University Affiliated Neoplasm Hospital
Jinan, Shandong, China
Investigator-assessed objective response rate (ORR)
Evaluate the investigator-assessed objective response rate (ORR) of JS207 combined with chemotherapy in the treatment of n first-line treatment of advanced non-small cell lung cancer (NSCLC) patients.The ORR is defined as the proportion of subjects who have a partial response (PR) or a complete response (CR) in the Best Overall Response.
Time frame: Up to approximately 25 months
Investigator-assessed objective response rate (DCR)
The DCR is defined as the proportion of subjects whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Time frame: Up to approximately 25 months
Investigator-assessed Progression-Free Survival (PFS)
The PFS is defined as the time from the first administration of the drug to the first documented disease progression (PD) according to the RECIST v1.1 criteria or death due to any disease (whichever occurs first).
Time frame: Up to approximately 25months
Investigator-assessed overall survival (OS)
The OS is defined as the time from the first administration of the drug to death due to any cause.
Time frame: Up to approximately 30 months
Adverse Event
Collect Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of signing the Informed Consent Form (ICF) until the safety follow-up visit.Evaluate the safety of the investigational drug.
Time frame: Up to approximately 25 months
Abnormal changes in laboratory
Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance
Time frame: Up to approximately 25 months
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