Shandong First Medical University Affiliated Neoplasm Hospital
Jinan, Shandong, 250117, China
Location status: Recruiting
NCT Number: NCT06969027
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Jinan, Shandong, 250117, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Up to approximately 25 months
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
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 25months
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 30 months
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 25 months
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
Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance
Time frame: Up to approximately 25 months
To characterize the trough concentrations of JS207
Time frame: Up to approximately 25 months
The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA)
Time frame: Up to approximately 25 months
The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable),the titer of ADA
Time frame: Up to approximately 5 months
Measuring the expression level of PD-L1 Protein in a Neoplasm tissue sample from a subject by an Immunohistochemistry assay
Contact information is provided by the study sponsor or research team.
Huiyu Lan, Master
CONTACT
Ying Zhang, Master
CONTACT
Shanghai Junshi Bioscience Co., Ltd.
Other
JS207 (PD-1/VEGF Dual Antibody) Combined With Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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