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

Shanghai Junshi Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Advanced NSCLC

Treatments: Drug: JS207 injection; Drug: JS207 injection +docetaxel; Drug: JS207 injection +JS004 injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06924606

JS207-004-II-NSCLC

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 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).
3. Subjects must have at least one measurable lesion according to RECIST v1.1.

Exclusion criteria

1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
2. Sensitivity mutation of EGFR or ALK fusion.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Arm A

Experimental group

Description:

Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.

Treatment:

Drug: JS207 injection +docetaxel

Arm B

Experimental group

Description:

Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.

Treatment:

Drug: JS207 injection +JS004 injection

Arm C

Experimental group

Description:

Patients receive JS207 10mg/kg or other dosage .

Treatment:

Drug: JS207 injection