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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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