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

NCT06924606 | Recruiting Phase 2

• 1 other identifier: JS207-004-II-NSCLC
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 18

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.

Conditions

Advanced NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)

  1.5years

Secondary Outcomes (6)

• Disease control rate (DCR)

  2years

• Duration of response (DOR)

  2years

• Progression-free survival (PFS)

  1.5years

• Overall survival (OS)

  2years

• AE

  2years

Other Outcomes (3)

• the trough concentrations (PK)

  1.5years

• Neutralizing antibody(Nab)

  1.5years

• Antidrug antibodies (ADA)

  1.5years

Study Arms (3)

Arm A

EXPERIMENTAL

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

Drug: JS207 injection +docetaxel

Arm B

EXPERIMENTAL

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

Drug: JS207 injection +JS004 injection

Arm C

EXPERIMENTAL

Patients receive JS207 10mg/kg or other dosage .

Drug: JS207 injection

Interventions

JS207 injection +JS004 injection DRUG

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

Arm B

JS207 injection DRUG

Patients receive JS207 10mg/kg or other dosage.

Arm C

JS207 injection +docetaxel DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (18)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101100, China

RECRUITING

Jilin Cancer Hospital

Jilin, Changchun, 130012, China

RECRUITING

Hunan Cancer Hospital

Hunan, Changsha, 410031, China

RECRUITING

West China Hospital, Sichuan University

Sichuan, Chengdu, 610044, China

RECRUITING

Second Affiliated Hospital, PLA Academy of Military Medical Sciences

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Army Medical Center, PLA

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, 510120, China

RECRUITING

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, 150081, China

RECRUITING

Anyang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

The First People's Hospital of Changde

Changde, Hunan, 415003, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Jiangxi, Nanchang, 330000, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

The Third People's Hospital of Datong

Datong, Shanxi, 037008, China

RECRUITING

Yibin Second People's Hospital

Yibin, Sichuan, 644000, China

RECRUITING

Affiliated Tumor Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, 830011, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, 200433, China

NOT YET RECRUITING

Central Study Contacts

Xiaojun Wang, Master

CONTACT

021-50796193; xiaojun_wang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)