Advanced NSCLCPhase 2NCT06924606
Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
A Phase 2 study testing JS207 injection +docetaxel, JS207 injection +JS004 injection and JS207 injection in people with Advanced NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced NSCLC
- What is being tested?
- JS207 injection +docetaxel, JS207 injection +JS004 injection and JS207 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 18 sitesChina
- Study dates
- 15 Jul 2025to 9 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Anyang Tumor Hospital
Anyang, Henan, 455000
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
The First People's Hospital of Changde
Changde, Hunan, 415003
Second Affiliated Hospital, PLA Academy of Military Medical Sciences
Chongqing, Chongqing Municipality, 400037
Army Medical Center, PLA
Chongqing, Chongqing Municipality, 400042
The Third People's Hospital of Datong
Datong, Shanxi, 037008
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510120
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, 150081
Hunan Cancer Hospital
Hunan, Changsha, 410031
The First Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, 330000
Jilin Cancer Hospital
Jilin City, Changchun, 130012
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shanghai Pulmonary Hospital
Shanghai, 200433
West China Hospital, Sichuan University
Sichuan, Chengdu, 610044
Affiliated Tumor Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, 830011
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Yibin Second People's Hospital
Yibin, Sichuan, 644000
About this study
Official 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
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
- Being tested
- JS207 injection +docetaxel, JS207 injection +JS004 injection, JS207 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207 injection +docetaxelDrug
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
JS207 injection +JS004 injectionDrug
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
JS207 injectionDrug
Patients receive JS207 10mg/kg or other dosage.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. Receives: Drug: JS207 injection +docetaxel |
| Arm B | Experimental | Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. Receives: Drug: JS207 injection +JS004 injection |
| Arm C | Experimental | Patients receive JS207 10mg/kg or other dosage . Receives: Drug: JS207 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1.5years
Secondary outcomes (6)
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)
Measured: 2years
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)
Measured: 2years
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)
Measured: 1.5years
Overall survival (OS)
To evaluate overall survival (OS)
Measured: 2years
AE
Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance
Measured: 2years
Abnormal changes in laboratory
Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Jul 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Why it stopped: The research and development strategy was adjusted, so the research was suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924606
- Sponsor's protocol ID
- JS207-004-II-NSCLC
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06924606
- Acronym / sponsor ID
- JS207-004-II-NSCLC
- Conditions
- Advanced NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research and development strategy was adjusted, so the research was suspended
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: JS207 injection +docetaxelPatients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. |
| Arm B | Experimental | Drug: JS207 injection +JS004 injectionPatients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. |
| Arm C | Experimental | Drug: JS207 injectionPatients receive JS207 10mg/kg or other dosage . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS207 injection +docetaxelPatients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. | Drug | Arm A |
| JS207 injection +JS004 injectionPatients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. | Drug | Arm B |
| JS207 injectionPatients receive JS207 10mg/kg or other dosage. | Drug | Arm C |
Primary outcome
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)
6 secondary outcomes
Disease control rate (DCR)
Time frame: 2years
Duration of response (DOR)
Time frame: 2years
Progression-free survival (PFS)
Time frame: 1.5years
Overall survival (OS)
Time frame: 2years
AE
Time frame: 2years
Abnormal changes in laboratory
Time frame: 2years
Results and safety
The study was stopped early (reason given: The research and development strategy was adjusted, so the research was suspended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS207 injection +docetaxel, JS207 injection +JS004 injection and JS207 injection in people with Advanced NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The research and development strategy was adjusted, so the research was suspended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1.5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.