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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06924606

Enrollment

Registered

2025-04-11

Start date

2025-07-15

Completion date

2026-06-26

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced NSCLC

Brief 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.

Interventions

DRUGJS207 injection +docetaxel

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

DRUGJS207 injection +JS004 injection

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

DRUGJS207 injection

Patients receive JS207 10mg/kg or other dosage.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Objective response rate (ORR)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)

Secondary

Measure	Time frame	Description
Disease control rate (DCR)	2years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Duration of response (DOR)	2years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Progression-free survival (PFS)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Overall survival (OS)	2years	To evaluate overall survival (OS)
AE	2years	Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance
Abnormal changes in laboratory	2years	Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance

Countries

China

Contacts

CONTACTXiaojun Wang, Master

xiaojun_wang@junshipharma.com021-50796193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026