Non-squamous Non-small Cell Lung CancerPhase 2NCT06868836
Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy
A Phase 2 study testing JS207, Pemetrexed and Carboplatin or cisplatin in people with Non-squamous Non-small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- JS207, Pemetrexed and Carboplatin or cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2025to 4 Apr 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.
- Locally advanced (stage IIIB/IIIC), metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
- Positive for driver genes, including but not limited to any of the following: EGFR sensitive mutations (18 exon G719X mutation, 19 exon deletion mutation, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 exon insertion mutation.
- Previous targeted therapy failed and there is currently no standard targeted treatment available.
- Cohort1: PD-L1 positive (TPS ≥ 1%) confirmed by the central laboratory or the research center. Cohort2:: Organized samples must be provided for the central laboratory to conduct retrospective biomarker testing (which may include PD-L1, EGFR and HER3 expression).
- Being able to provide a qualified test report for positive driver gene, or agreeing to provide a qualified sample for driver gene testing.
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- According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.
- Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Expected survival period ≥ 12 weeks.
- The function of important organs meets the requirements of the protocol.
- For female subjects with reproductive capacity who have sexual relations with unsterilized male partners, they must agree to have no pregnancy plans and to take effective contraceptive measures during the period from signing the ICF to 7 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement). For unsterilized male subjects who maintain sexual relations with female partners with reproductive capacity, they must agree to take effective contraceptive measures during the period from signing the ICF to 4 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement) (Appendix 4). For female patients with reproductive capacity, the HCG test in the 7 days prior to study enrollment must be negative and they must be non-lactating.
- Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.
Who cannot join
- Diseases accompanied by those listed in the protocol, including those with histopathological or cytopathological confirmation of the tumor combined with neuroendocrine tumor (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) components, or with the squamous cell carcinoma component exceeding 10%; known meningeal metastasis; symptomatic brain metastasis; the tumor encircling important blood vessels or with obvious necrosis and cavities, and the investigator deems that it may pose a risk of bleeding, etc.
- Received the treatments listed in the plan, including immune-mediated treatments; systemic chemotherapy, anti-VEGF pathway target drugs, anti-EGFR and/or HER3 target drugs, and ADC drugs containing topoisomerase inhibitors (only applicable to cohort 2).
- Having an obvious bleeding tendency or a history of severe coagulation dysfunction.
- Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation/fistula formation of the hollow viscus as judged by the investigator.
- Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.
- Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
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- Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).
- Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin/cisplatin), or known history of ≥ grade 3 allergy to antibody drugs in the past.
- Having an active autoimmune disease or a history of autoimmune disease.
- Having a history of immunodeficiency.
- Having a severe infection within 4 weeks before the first use of the investigational drug.
- History of confirmed or suspected interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonia, idiopathic pneumonia, or other moderate to severe lung diseases that seriously affect lung function.
- Active pulmonary tuberculosis infection detected by medical history or CT examination.
- Having active tuberculosis, hepatitis B, or hepatitis C.
- Having been diagnosed with any other malignant tumor within 5 years before the first use of the investigational drug.
- Uncontrolled concurrent diseases listed in the protocol.
- As judged by the investigator, having other severe, acute or chronic medical diseases, mental diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results. "
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provicial People's Hospital
Guangzhou, Guangdong, 510080
Yilong Wu, Ph.D, 020-83525210, syylwu@live.cn
Yilong Wu, Ph.D
About this study
This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg/m², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
Read the detailed description
This study enrolls patients with advanced non-small cell lung cancer (NSCLC) who have positive driver genes and have failed TKI treatment.
Approximately 66-78 patients are expected to be enrolled and receive treatment. Cohort1 ：JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles.After the 4 cycles, patients will continue receiving JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) every 3 weeks (Q3W) until they meet the criteria for treatment discontinuation. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- JS207, Pemetrexed, Carboplatin or cisplatin, JS212
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207Drug
JS207 (10 mg/kg or 15 mg/kg, IV, d1)
PemetrexedDrug
Pemetrexed (500 mg/m², IV, d1)
Carboplatin or cisplatinDrug
Platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles
JS212Drug
JS212(4.2mg/Kg or Other dose， IV, d1）
| Study group | Role | What they receive |
|---|---|---|
| JS207 + pemetrexed+ platinum-based chemotherapy | Experimental | Not described Receives: Drug: JS207; Drug: Pemetrexed; Drug: Carboplatin or cisplatin |
| JS207+JS212 | Experimental | Not described Receives: Drug: JS207; Drug: JS212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed objective response rate (ORR)
Evaluate the investigator-assessed objective response rate (ORR) of JS207 combined withTherapies in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC) patients with positive driver genes and who have failed tyrosine kinase inhibitor (TKI) therapy.The ORR is defined as the proportion of subjects who have a partial response (PR) or a complete response (CR) in the Best Overall Response.
Measured: Up to approximately 37 months
Secondary outcomes (6)
Investigator-assessed objective response rate (DCR)
The DCR is defined as the proportion of subjects whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Measured: Up to approximately 37 months
Investigator-assessed Duration of Response (DoR)
The DoR is defined as the time from the first occurrence of CR or PR to the first occurrence of Progressive Disease (PD) or death (whichever occurs first). The DoR is only applicable to subjects whose BOR is CR or PR
Measured: Up to approximately 37 months
Investigator-assessed Progression-Free Survival (PFS)
The PFS is defined as the time from the first administration of the drug to the first documented disease progression (PD) according to the RECIST v1.1 criteria or death due to any disease (whichever occurs first)
Measured: Up to approximately 37 months
Investigator-assessed overall survival (OS)
The OS is defined as the time from the first administration of the drug to death due to any cause
Measured: Up to approximately 37 months
Adverse Event
Collect Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of signing the Informed Consent Form (ICF) until the safety follow-up visit.Evaluate the safety of the investigational drug
Measured: Up to approximately 37 months
Number of participants with Laboratory examination indices
Collect all laboratory examinations during the study period or the safety follow-up period. The investigator must review the laboratory examination results, record the review findings, and record any clinically significant changes that occur during the study period as Adverse Events. Evaluate the safety of the investigational drug
Measured: Up to approximately 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start30 Mar 2025
- Primary completion4 Sep 2026 (estimated)
- Study completion4 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies 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
- Model description
- Cohort1 ：JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weihua Wang, Doctor, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868836
- Sponsor's protocol ID
- JS207-002-II-NSCLC
- Status last verified
- May 2026
- First submitted
- 4 Mar 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy
- ClinicalTrials.gov ID
- NCT06868836
- Acronym / sponsor ID
- JS207-002-II-NSCLC
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 4 Apr 2028 (estimated)
- First posted
- 11 Mar 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 study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg/m², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
Detailed description
This study enrolls patients with advanced non-small cell lung cancer (NSCLC) who have positive driver genes and have failed TKI treatment.
Approximately 66-78 patients are expected to be enrolled and receive treatment. Cohort1 ：JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles.After the 4 cycles, patients will continue receiving JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) every 3 weeks (Q3W) until they meet the criteria for treatment discontinuation. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort1 ：JS207 (10 mg/kg or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles. Cohort2 ：The treatment received was JS207 (10mg/kg, intravenous, on day 1) + JS212 (4.2mg/kg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met.
| Arm | Type | Receives |
|---|---|---|
| JS207 + pemetrexed+ platinum-based chemotherapy | Experimental | Drug: JS207, Drug: Pemetrexed, Drug: Carboplatin or cisplatin |
| JS207+JS212 | Experimental | Drug: JS207, Drug: JS212 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.
- Locally advanced (stage IIIB/IIIC), metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
- Positive for driver genes, including but not limited to any of the following: EGFR sensitive mutations (18 exon G719X mutation, 19 exon deletion mutation, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 exon insertion mutation.
- Previous targeted therapy failed and there is currently no standard targeted treatment available.
- Cohort1: PD-L1 positive (TPS ≥ 1%) confirmed by the central laboratory or the research center. Cohort2:: Organized samples must be provided for the central laboratory to conduct retrospective biomarker testing (which may include PD-L1, EGFR and HER3 expression).
Key exclusion criteria (17 listed)
- Diseases accompanied by those listed in the protocol, including those with histopathological or cytopathological confirmation of the tumor combined with neuroendocrine tumor (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) components, or with the squamous cell carcinoma component exceeding 10%; known meningeal metastasis; symptomatic brain metastasis; the tumor encircling important blood vessels or with obvious necrosis and cavities, and the investigator deems that it may pose a risk of bleeding, etc.
- Received the treatments listed in the plan, including immune-mediated treatments; systemic chemotherapy, anti-VEGF pathway target drugs, anti-EGFR and/or HER3 target drugs, and ADC drugs containing topoisomerase inhibitors (only applicable to cohort 2).
- Having an obvious bleeding tendency or a history of severe coagulation dysfunction.
- Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation/fistula formation of the hollow viscus as judged by the investigator.
- Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.
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 |
|---|---|---|
| JS207JS207 (10 mg/kg or 15 mg/kg, IV, d1) | Drug | JS207 + pemetrexed+ platinum-based chemotherapy, JS207+JS212 |
| PemetrexedPemetrexed (500 mg/m², IV, d1) | Drug | JS207 + pemetrexed+ platinum-based chemotherapy |
| Carboplatin or cisplatinPlatinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles | Drug | JS207 + pemetrexed+ platinum-based chemotherapy |
| JS212JS212(4.2mg/Kg or Other dose， IV, d1） | Drug | JS207+JS212 |
Primary outcome
Investigator-assessed objective response rate (ORR)
Time frame: Up to approximately 37 months
Evaluate the investigator-assessed objective response rate (ORR) of JS207 combined withTherapies in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC) patients with positive driver genes and who have failed tyrosine kinase inhibitor (TKI) therapy.The ORR is defined as the proportion of subjects who have a partial response (PR) or a complete response (CR) in the Best Overall Response.
6 secondary outcomes
Investigator-assessed objective response rate (DCR)
Time frame: Up to approximately 37 months
Investigator-assessed Duration of Response (DoR)
Time frame: Up to approximately 37 months
Investigator-assessed Progression-Free Survival (PFS)
Time frame: Up to approximately 37 months
Investigator-assessed overall survival (OS)
Time frame: Up to approximately 37 months
Adverse Event
Time frame: Up to approximately 37 months
Number of participants with Laboratory examination indices
Time frame: Up to approximately 37 months
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 18 May 2026.
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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.
Weihua Wang, Doctor study director
Medical Director
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 JS207, Pemetrexed and Carboplatin or cisplatin in people with Non-squamous Non-small Cell Lung Cancer, 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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 18 May 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?
Contact Mei Yue, Master (86 15898908882, mei_yue@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed objective response rate (ORR) (time frame: Up to approximately 37 months). 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 18 May 2026.