NSCLCPhase 2NCT06944470
JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC
A Phase 2 study testing Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, surgery and Radiochemotherapy in people with NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC
- What is being tested?
- Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, surgery and Radiochemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years at the time of signing the informed consent (inclusive of 18 and 75 years), either gender.
- Histologically confirmed, previously untreated stage II-III NSCLC (AJCC 8th edition), cTNM stage can be confirmed by PET-CT or pathological biopsy. For suspicious lesions that are suspected by imaging examination, which can lead to changes in TNM stage, including but not limited to contralateral mediastinal lymph nodes and supraclavicular lymph nodes, pathological biopsy verification is strongly recommended.
- Cohort 1: Subjects with resectable, stage II, IIIA, or IIIB (N2) NSCLC evaluated by MDT.
- Cohort 2: Subjects with unresectable, stage III NSCLC evaluated by MDT.
- Total lung function can withstand the proposed lung resection procedure according to the surgeon's evaluation.
- Subjects without EGFR sensitive mutation, ALK fusion, ROS1 fusion or RET fusion. Subjects with squamous cell carcinoma are not required to undergo genetic testing. The Certificate of Analysis from the local laboratory is acceptable, but the test must be well validated and approved by the inter-laboratory quality assessment or NMPA (if the mutation is negative in blood test, it must be confirmed based on the results from tissue sample); if there is no previous Certificate of Analysis or the previous Certificate of Analysis does not meet the requirements, the sample should be provided for testing.
- At least 3 unstained tumor tissue sections were available for detection of PD-L1 and other biomarkers. If truly unable to provide tumor tissue samples as required, enrollment was also possible after communication with the sponsor.
- Function of vital organs meets the requirements.
Who cannot join
- In the company of the following study disease status:
- Histopathologically or cytologically confirmed combined components of neuroendocrine tumours (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) and Pancoast tumor.
- Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
- Any clinically significant hemoptysis (≥2.5 ml) or Tumour haemorrhage of any cause within one month before the first use of the study drug.
- Received any of the following treatments:
- Previous systemic antitumor therapy for NSCLC (including investigational drugs), such as chemotherapy or immunologically mediated therapy (including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy) and anti-angiogenic therapy (such as anti-VEGF pathway-targeted drugs);
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- Prior radiotherapy to chest;
- History of significant Haemorrhagic diathesis or severe Disorder coagulation, or Grade ≥3 bleeding event within 6 months prior to the first dose, or current ≥Grade 2 bleeding or factors that are judged by the investigator to be at high risk for bleeding (e.g., active peptic ulcer or Varices oesophageal).
- Gastrointestinal perforation, intra-abdominal fistula, or intra-abdominal abscess within 6 months prior to the first dose, or current risk factors for perforation/fistula formation of hollow organs as judged by the investigator, such as tumor invasion of the outer layer of hollow organ wall, or active inflammatory bowel disease (including Colitis ulcerative and Crohn's disease), Diverticulitis, Cholecystitis, symptomatic Cholangitis or Appendicitis.
- Existence of poorly controlled Hypertension, or history of Hypertensive crisis or Hypertensive encephalopathy.
- Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except Vitiligo or childhood asthma/allergy that has been cured, patients who do not require any intervention after adulthood, patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, patients with hyperthyroidism adequately treated and well-controlled, and patients with type I Diabetes mellitus treated with a stable dose of Insulin, etc.
- Uncontrolled co-morbidities, including but not limited to: symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) <50%, unstable angina, treated arrhythmia, aortic aneurysm requiring surgical repair, any arterial thrombotic/embolic events, Grade 3 or higher (CTCAE 5.0) venous thrombotic/embolic events, transient ischemic attack, cerebrovascular accident, tracheoesophageal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal obstruction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: JS207 (Anti-PD-1/VEGF Bispecific Antibody) Combined With Platinum-based Doublet Chemotherapy in Subjects With Stage II-III Non-small Cell Lung Cancer
This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).
- Conditions
- NSCLC
- Being tested
- Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, surgery, Radiochemotherapy, JS207
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinomaDrug
Carboplatin Injection:
One dose of carboplatin AUC 5 IV on Day 1 of each 3-week cycle.
Cisplatin injection:
Cisplatin 75 mg/m2 IV on Day 1 of every 3-week cycle.
Paclitaxel injection:
175 mg/m2 IV on Day 1 of each 3-week cycle.
Pemetrexed Injection:
Pemetrexed 500 mg/m2 IV on Day 1 of each 3-week cycle.
surgeryProcedure or surgery
Subjects with surgical indications will undergo radical surgery for NSCLC，within 4-6 weeks after the last dose of neoadjuvant therapy.
RadiochemotherapyRadiation
If radical surgery is not suitable after MDT evaluation, the subjects will receive comprehensive treatment mainly based on radiotherapy.
JS207Drug
JS207 will be administered every 3 weeks for a treatment cycle of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207） | Experimental | Preoperative neoadjuvant therapy phase, the receive JS207 + platinum-based double chemotherapyonce every 3 weeks，then perform Surgical treatment，after that，perform postoperative ADJUVANT THERAPY （JS207） Receives: Drug: Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma; Procedure: surgery; Drug: JS207 |
| Cohort2：enrolled untreated, stage III NSCLC patients（JS207） | Experimental | Preoperative neoadjuvant therapy phase, the receive JS207 + platinum-based double chemotherapyonce every 3 weeks，then perform Surgical treatment or CRT，after that，perform postoperative ADJUVANT THERAPY （JS207） Receives: Drug: Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma; Procedure: surgery; Radiation: Radiochemotherapy; Drug: JS207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR rate
To evaluate the pathologic complete response rate (pCR rate) of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.
Measured: 2 years
Secondary outcomes (5)
MPR rate
To evaluate the pathologic MPR rate of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.
Measured: 2 years
EFS
Time from the beginning of randomization until disease progression under the RECIST1.1 criteria is first recorded leading to inoperable or CRT, local progression leading to inoperable tumor resection or CRT, CRT or postoperative disease recurrence or progression, or death from any cause, whichever occurs first
Measured: 2 years
ORR
Subjects with partial response (PR) or complete response (CR) at BOR
Measured: 2 years
DCR
Proportion of subjects with CR, PR, or stable disease (SD) at BOR
Measured: 2 years
OS
The time from first dose to death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start20 May 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT06944470
- Sponsor's protocol ID
- JS207-005-II-NSCLC
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JS207 (Anti-PD-1/VEGF Bispecific Antibody) Combined With Platinum-based Doublet Chemotherapy in Subjects With Stage II-III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06944470
- Acronym / sponsor ID
- JS207-005-II-NSCLC
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 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 phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207） | Experimental | Drug: Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, Procedure: surgery, Drug: JS207Preoperative neoadjuvant therapy phase, the receive JS207 + platinum-based double chemotherapyonce every 3 weeks，then perform Surgical treatment，after that，perform postoperative ADJUVANT THERAPY （JS207） |
| Cohort2：enrolled untreated, stage III NSCLC patients（JS207） | Experimental | Drug: Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, Procedure: surgery, Radiation: Radiochemotherapy, Drug: JS207Preoperative neoadjuvant therapy phase, the receive JS207 + platinum-based double chemotherapyonce every 3 weeks，then perform Surgical treatment or CRT，after that，perform postoperative ADJUVANT THERAPY （JS207） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years at the time of signing the informed consent (inclusive of 18 and 75 years), either gender.
- Histologically confirmed, previously untreated stage II-III NSCLC (AJCC 8th edition), cTNM stage can be confirmed by PET-CT or pathological biopsy. For suspicious lesions that are suspected by imaging examination, which can lead to changes in TNM stage, including but not limited to contralateral mediastinal lymph nodes and supraclavicular lymph nodes, pathological biopsy verification is strongly recommended.
- Total lung function can withstand the proposed lung resection procedure according to the surgeon's evaluation.
- Subjects without EGFR sensitive mutation, ALK fusion, ROS1 fusion or RET fusion. Subjects with squamous cell carcinoma are not required to undergo genetic testing. The Certificate of Analysis from the local laboratory is acceptable, but the test must be well validated and approved by the inter-laboratory quality assessment or NMPA (if the mutation is negative in blood test, it must be confirmed based on the results from tissue sample); if there is no previous Certificate of Analysis or the previous Certificate of Analysis does not meet the requirements, the sample should be provided for testing.
- At least 3 unstained tumor tissue sections were available for detection of PD-L1 and other biomarkers. If truly unable to provide tumor tissue samples as required, enrollment was also possible after communication with the sponsor.
Key exclusion criteria (12 listed)
- In the company of the following study disease status:
- Received any of the following treatments:
- History of significant Haemorrhagic diathesis or severe Disorder coagulation, or Grade ≥3 bleeding event within 6 months prior to the first dose, or current ≥Grade 2 bleeding or factors that are judged by the investigator to be at high risk for bleeding (e.g., active peptic ulcer or Varices oesophageal).
- Gastrointestinal perforation, intra-abdominal fistula, or intra-abdominal abscess within 6 months prior to the first dose, or current risk factors for perforation/fistula formation of hollow organs as judged by the investigator, such as tumor invasion of the outer layer of hollow organ wall, or active inflammatory bowel disease (including Colitis ulcerative and Crohn's disease), Diverticulitis, Cholecystitis, symptomatic Cholangitis or Appendicitis.
- Existence of poorly controlled Hypertension, or history of Hypertensive crisis or Hypertensive encephalopathy.
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 |
|---|---|---|
| Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinomaCarboplatin Injection: One dose of carboplatin AUC 5 IV on Day 1 of each 3-week cycle. Cisplatin injection: Cisplatin 75 mg/m2 IV on Day 1 of every 3-week cycle. Paclitaxel injection: 175 mg/m2 IV on Day 1 of each 3-week cycle. Pemetrexed Injection: Pemetrexed 500 mg/m2 IV on Day 1 of each 3-week cycle. | Drug | Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207）, Cohort2：enrolled untreated, stage III NSCLC patients（JS207） |
| surgerySubjects with surgical indications will undergo radical surgery for NSCLC，within 4-6 weeks after the last dose of neoadjuvant therapy. | Procedure or surgery | Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207）, Cohort2：enrolled untreated, stage III NSCLC patients（JS207） |
| RadiochemotherapyIf radical surgery is not suitable after MDT evaluation, the subjects will receive comprehensive treatment mainly based on radiotherapy. | Radiation | Cohort2：enrolled untreated, stage III NSCLC patients（JS207） |
| JS207JS207 will be administered every 3 weeks for a treatment cycle of 21 days. | Drug | Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207）, Cohort2：enrolled untreated, stage III NSCLC patients（JS207） |
Primary outcome
PCR rate
Time frame: 2 years
To evaluate the pathologic complete response rate (pCR rate) of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.
5 secondary outcomes
MPR rate
Time frame: 2 years
EFS
Time frame: 2 years
ORR
Time frame: 2 years
DCR
Time frame: 2 years
OS
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma, surgery and Radiochemotherapy in people with NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
PCR rate (time frame: 2 years). 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 27 Jul 2026.