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NCT Number: NCT06924606

Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chest Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

JS207 injection +docetaxel

Drug

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

JS207 injection +JS004 injection

Drug

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

JS207 injection

Drug

Patients receive JS207 10mg/kg or other dosage.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Overall survival (OS)

    Time frame: 2years

    To evaluate overall survival (OS)

  5. AE

    Time frame: 2years

    Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance

  6. Abnormal changes in laboratory

    Time frame: 2years

    Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance

Other outcomes

  1. the trough concentrations (PK)

    Time frame: 1.5years

    to characterize the tough concentration of JS207&JS004

  2. Neutralizing antibody(Nab)

    Time frame: 1.5years

    to characterize the neutralizing antibody of JS207&JS004

  3. Antidrug antibodies (ADA)

    Time frame: 1.5years

    to characterize antidrug antibodies of JS207&JS004

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojun Wang, Master

CONTACT

[email protected]

021-50796193

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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