CClinicalTrials.gg
Sign In
TerminatedNCT06924606Updated Sep 25, 2026

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

A Phase 2 interventional study of JS207 injection +docetaxel and JS207 injection +JS004 injection in Advanced NSCLC, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Terminated at 18 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
The research and development strategy was adjusted, so the research was suspended
Updated Sep 25, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced NSCLC
03

In context

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Arm A

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

    Drug: JS207 injection +docetaxel

  • Experimental
    Arm B

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

    Drug: JS207 injection +JS004 injection

  • Experimental
    Arm C

    Patients receive JS207 10mg/kg or other dosage .

    Drug: JS207 injection

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.

06

What researchers measure

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)

    Time frame: 1.5years

Secondary outcomes

  1. Disease control rate (DCR)

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)

    Time frame: 2years

  2. Duration of response (DOR)

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)

    Time frame: 2years

  3. Progression-free survival (PFS)

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)

    Time frame: 1.5years

  4. Overall survival (OS)

    To evaluate overall survival (OS)

    Time frame: 2years

  5. AE

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

    Time frame: 2years

  6. Abnormal changes in laboratory

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

    Time frame: 2years

Other outcomes

  1. the trough concentrations (PK)

    to characterize the tough concentration of JS207\&JS004

    Time frame: 1.5years

  2. Neutralizing antibody(Nab)

    to characterize the neutralizing antibody of JS207\&JS004

    Time frame: 1.5years

  3. Antidrug antibodies (ADA)

    to characterize antidrug antibodies of JS207\&JS004

    Time frame: 1.5years

07

Study locations

18 sites
  • Beijing Chest Hospital, Capital Medical University
    Beijing, Beijing Municipality 101100, China
  • Jilin Cancer Hospital
    Jilin City, Changchun 130012, China
  • Hunan Cancer Hospital
    Hunan, Changsha 410031, China
  • West China Hospital, Sichuan University
    Sichuan, Chengdu 610044, China
  • Second Affiliated Hospital, PLA Academy of Military Medical Sciences
    Chongqing, Chongqing Municipality 400037, China
  • Army Medical Center, PLA
    Chongqing, Chongqing Municipality 400042, China
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangdong, Guangzhou 510120, China
  • Harbin Medical University Cancer Hospital
    Heilongjiang, Harbin 150081, China
  • Anyang Tumor Hospital
    Anyang, Henan 455000, China
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 471003, China
  • The First Affiliated Hospital of Xinxiang Medical University
    Xinxiang, Henan 453100, China
  • The First People's Hospital of Changde
    Changde, Hunan 415003, China
  • The First Affiliated Hospital of Nanchang University
    Jiangxi, Nanchang 330000, China
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
  • The Third People's Hospital of Datong
    Datong, Shanxi 037008, China
  • Yibin Second People's Hospital
    Yibin, Sichuan 644000, China
  • Affiliated Tumor Hospital of Xinjiang Medical University
    Xinjiang, Xinjiang 830011, China
  • Shanghai Pulmonary Hospital
    Shanghai, 200433, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Terminated The research and development strategy was adjusted, so the research was suspended
changed Sep 25, 2026
Primary completion
Jun 26, 2026→Jul 9, 2026 (actual)
Sep 25, 2026
Study completion
Jun 26, 2026→Jul 9, 2026 (actual)
Sep 25, 2026
Enrollment
66 (estimated)→18 (actual)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Recruiting→Terminated
    Why stopped The research and development strategy was adjusted, so the research was suspended
    Primary completion Jun 26, 2026→Jul 9, 2026 (now actual)
    Study completion Jun 26, 2026→Jul 9, 2026 (now actual)
    Enrollment 66 (estimated)→18 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06924606
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Responsible party
Sponsor
First posted
Apr 11, 2025
Start date
Jul 15, 2025
Primary completion
Jul 9, 2026
Completion
Jul 9, 2026
Last update
Sep 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Shanghai Junshi Bioscience Co., Ltd.

Start the discussion