RecruitingPhase 2NCT06924606

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


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

66 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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.


Locations(18)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Jilin Cancer Hospital

Jilin, Changchun, China

Hunan Cancer Hospital

Hunan, Changsha, China

West China Hospital, Sichuan University

Sichuan, Chengdu, China

Second Affiliated Hospital, PLA Academy of Military Medical Sciences

Chongqing, Chongqing Municipality, China

Army Medical Center, PLA

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China

Anyang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

The First People's Hospital of Changde

Changde, Hunan, China

The First Affiliated Hospital of Nanchang University

Jiangxi, Nanchang, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The Third People's Hospital of Datong

Datong, Shanxi, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Affiliated Tumor Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

Shanghai Pulmonary Hospital

Shanghai, China

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NCT06924606


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