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This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 :Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg/m², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 :The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
This study enrolls patients with advanced non-small cell lung cancer (NSCLC) who have positive driver genes and have failed TKI treatment.
Approximately 66-78 patients are expected to be enrolled and receive treatment. Cohort1 :JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles.After the 4 cycles, patients will continue receiving JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) every 3 weeks (Q3W) until they meet the criteria for treatment discontinuation. Cohort2 :The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS207 + pemetrexed+ platinum-based chemotherapy | Experimental |
| |
| JS207+JS212 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS207 | Drug | JS207 (10 mg/kg or 15 mg/kg, IV, d1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed objective response rate (ORR) | Evaluate the investigator-assessed objective response rate (ORR) of JS207 combined withTherapies in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC) patients with positive driver genes and who have failed tyrosine kinase inhibitor (TKI) therapy.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. | Up to approximately 37 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to approximately 37 months |
| Investigator-assessed Duration of Response (DoR) |
| Measure | Description | Time Frame |
|---|---|---|
| the trough concentrations (PK) | To characterize the trough concentrations of JS207 | Up to approximately 37 months |
| Immunogenicity(ADA) | The immunogenicity of JS207, including the titer of ADA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Yue, Master | Contact | 86 15898908882 | mei_yue@junshipharma.com | |
| Huiyu Lan, Master | Contact | 15000239047 | huiyu_lan@junshipharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Weihua Wang, Doctor | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provicial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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Cohort1 :JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles.
Cohort2 :The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
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| Pemetrexed | Drug | Pemetrexed (500 mg/m², IV, d1) |
|
| Carboplatin or cisplatin | Drug | Platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles |
|
| JS212 | Drug | JS212(4.2mg/Kg or Other dose, IV, d1) |
|
The DoR is defined as the time from the first occurrence of CR or PR to the first occurrence of Progressive Disease (PD) or death (whichever occurs first). The DoR is only applicable to subjects whose BOR is CR or PR |
| Up to approximately 37 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) | Up to approximately 37 months |
| 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 | Up to approximately 37 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 | Up to approximately 37 months |
| Number of participants with Laboratory examination indices | Collect all laboratory examinations during the study period or the safety follow-up period. The investigator must review the laboratory examination results, record the review findings, and record any clinically significant changes that occur during the study period as Adverse Events. Evaluate the safety of the investigational drug | Up to approximately 37 months |
| Up to approximately 37 months |
| Immunogenicity(NAb) | The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable) | Up to approximately 37 months |
| Expression level of PD-L1 in tumor tissues | The correlation between the expression level of PD-L1 in tumor tissues and the therapeutic effect | Up to approximately 37 months |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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