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

February 4, 2026 updated by: Shanghai Junshi Bioscience Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200433
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Principal Investigator:
          • Chunxia Su, Doctor
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 101100
        • Recruiting
        • Beijing Chest Hospital, Capital Medical University
        • Contact:
          • Tongmei Zhang, Doctor
        • Principal Investigator:
          • Tongmei Zhang, Doctor
    • Changchun
      • Jilin, Changchun, China, 130012
        • Recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Liu, Doctor
        • Contact:
          • Ying Liu, Doctor
    • Changsha
      • Hunan, Changsha, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Lin Wu, Doctor
        • Contact:
          • Lin Wu, Doctor
    • Chengdu
      • Sichuan, Chengdu, China, 610044
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Panwen Tian, Doctor
        • Principal Investigator:
          • Panwen Tian, Doctor
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Recruiting
        • Second Affiliated Hospital, PLA Academy of Military Medical Sciences
        • Contact:
        • Principal Investigator:
          • Bo Zhu, Doctor
      • Chongqing, Chongqing Municipality, China, 400042
        • Recruiting
        • Army Medical Center, PLA
        • Contact:
          • Mengxia Li, Doctor
        • Principal Investigator:
          • Mengxia Li, Doctor
    • Guangzhou
      • Guangdong, Guangzhou, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Chengzhi Zhou, Doctor
        • Principal Investigator:
          • Chengzhi Zhou, Doctor
    • Harbin
      • Heilongjiang, Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yan Yu, Doctor
        • Contact:
          • Yan Yu, Doctor
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Yuanyuan Ji, Doctor
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Zhiye Zhang, Doctor
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
        • Principal Investigator:
          • Yinghua Ji, Doctor
    • Hunan
      • Changde, Hunan, China, 415003
        • Recruiting
        • The First People's Hospital of Changde
        • Contact:
        • Principal Investigator:
          • Zhijun Wu, Doctor
    • Nanchang
      • Jiangxi, Nanchang, China, 330000
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Longhua Sun, Doctor
        • Principal Investigator:
          • Longhua Sun, Doctor
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
          • Peng Zhang, Doctor
        • Principal Investigator:
          • Peng Zhang, Doctor
    • Shanxi
      • Datong, Shanxi, China, 037008
        • Recruiting
        • The Third People's Hospital of Datong
        • Contact:
        • Principal Investigator:
          • Chengxun Cui, Doctor
    • Sichuan
      • Yibin, Sichuan, China, 644000
        • Recruiting
        • Yibin Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Xujuan Ye, Doctor
    • Xinjiang
      • Xinjiang, Xinjiang, China, 830011
        • Recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Zhigang Han, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
Drug: JS207 injection +docetaxel
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
Experimental: Arm B
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
Drug: JS207 injection +JS004 injection
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
Experimental: Arm C
Patients receive JS207 10mg/kg or other dosage .
Drug: JS207 injection
Patients receive JS207 10mg/kg or other dosage.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the trough concentrations (PK)
Time Frame: 1.5years
to characterize the tough concentration of JS207&JS004
1.5years
Neutralizing antibody(Nab)
Time Frame: 1.5years
to characterize the neutralizing antibody of JS207&JS004
1.5years
Antidrug antibodies (ADA)
Time Frame: 1.5years
to characterize antidrug antibodies of JS207&JS004
1.5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

June 26, 2026

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS207-004-II-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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