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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS207+ Pemetrexed + a platinum | Experimental | Enrolling 30-42 Non-squamous non-small cell lung cancerparticipants,Patients will receive 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. |
|
| JS207+ Paclitaxel + a platinum | Experimental | Enrolling 30-42 squamous non-small cell lung cancerparticipants,Patients will receive 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. |
|
| 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 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. | Up to approximately 25 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 25 months |
| Investigator-assessed Progression-Free Survival (PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| PK | To characterize the trough concentrations of JS207 | Up to approximately 25 months |
| Immunogenicity (ADA) | The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhang, Master | Contact | 18616904609 | ying_zhang2@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 |
|---|---|---|---|---|---|---|
| Shandong First Medical University Affiliated Neoplasm Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D010984 | Platinum |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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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.
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.
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| Pemetrexed injection | Drug | Pemetrexed (500 mg/m2 IV, D1) |
|
| Platinum | Drug | Platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1) |
|
| Paclitaxel | Drug | Paclitaxel (175 mg/m2 IV, D1) |
|
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 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. | 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. | Up to approximately 25 months |
| Abnormal changes in laboratory | Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance | Up to approximately 25 months |
| Up to approximately 25 months |
| Immunogenicity (Nab) | The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable),the titer of ADA | Up to approximately 25 months |
| Expression level of PD-L1 in tumor tissues | Measuring the expression level of PD-L1 Protein in a Neoplasm tissue sample from a subject by an Immunohistochemistry assay | Up to approximately 5 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |