Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
A Phase II Study of JS207 (PD-1/VEGF Dual Antibody) in Combination With or Without JS004 or Docetaxel in Advanced Non-small Cell Lung Cancer With Disease Progression During or After the Treatment of Platinum-based Chemotherapy and Immunotherapy
Shanghai Junshi Bioscience Co., Ltd.
66 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
Summary
This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
Eligibility
Inclusion Criteria3
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
- Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1/PD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1/PD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).
- Subjects must have at least one measurable lesion according to RECIST v1.1.
Exclusion Criteria3
- Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
- Sensitivity mutation of EGFR or ALK fusion.
- Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Interventions
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
Patients receive JS207 10mg/kg or other dosage.
Locations(18)
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NCT06924606