Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • JS207 injection +docetaxel
  • JS207 injection +JS004 injection
  • JS207 injection

Treatment groups

66 Participants
are divided into 3 treatment groups