A Phase 2 interventional study of JS207 and Pemetrexed injection in Non-small Cell Lung Cancer, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 69 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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.
Drug: JS207 · Drug: Pemetrexed injection · Drug: Platinum
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.
Drug: JS207 · Drug: Platinum · Drug: Paclitaxel
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)
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
PK
To characterize the trough concentrations of JS207
Time frame: Up to approximately 25 months
Immunogenicity (ADA）
The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA)
Time frame: 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
Time frame: 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
Time frame: Up to approximately 5 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shanghai Junshi Bioscience Co., Ltd.