A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer

NCT ID: NCT06868836

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2027-04-30

Brief Summary

This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 36-42 participants. Patients will receive JS207 (10 or 15 mg/kg, IV, d1) + pemetrexed (500 mg/m², IV, d1) + platinum-based chemotherapy (carboplatin AUC5 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. 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 36-42 patients are expected to be enrolled and receive treatment with 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.The study aims to evaluate the safety, tolerability, and preliminary efficacy of JS207 in combination with pemetrexed and platinum-based chemotherapy.

Conditions

Non-squamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS207 + pemetrexed+ platinum-based chemotherapy

If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.

Group Type: EXPERIMENTAL

JS207

Intervention Type: DRUG

JS207 (10 mg/kg or 15 mg/kg, IV, d1)

Pemetrexed

Intervention Type: DRUG

Pemetrexed (500 mg/m², IV, d1)

Carboplatin or cisplatin

Intervention Type: DRUG

Platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles

Interventions

JS207

JS207 (10 mg/kg or 15 mg/kg, IV, d1)

Intervention Type: DRUG

Pemetrexed

Pemetrexed (500 mg/m², IV, d1)

Intervention Type: DRUG

Carboplatin or cisplatin

Platinum-based chemotherapy (carboplatin: AUC5, d1 or cisplatin 75 mg/m², d1) every 3 weeks (Q3W) for a total of 4 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Positive for driver gene and having received the first-line targeted therapy approved by the National Medical Products Administration (NMPA).

4. Failure of previous tyrosine kinase inhibitor (TKI) treatment and currently having no standard TKI treatment available.

5. Positive for PD-L1 (tumor proportion score, TPS ≥ 1%) confirmed by the central laboratory test or local test.

6. Being able to provide a qualified test report for positive driver gene, or agreeing to provide a qualified sample for driver gene testing.

7. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.

8. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.

9. Expected survival period ≥ 12 weeks.

10. The function of important organs meets the requirements of the protocol.

11. Female subjects of childbearing potential, and male subjects whose partners are females of childbearing age, need to adopt a highly effective contraceptive measure during the study treatment period and for at least 6 months after the last administration.

12. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.

Exclusion Criteria

1. 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.

2. Treatment received as listed in the protocol, including immunologically mediated treatment; drugs targeting the anti-VEGF pathway, etc.

3. Having an obvious bleeding tendency or a history of severe coagulation dysfunction.

4. 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.

5. Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.

6. Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.

7. 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).

8. 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.

9. Having an active autoimmune disease or a history of autoimmune disease.

10. Having a history of immunodeficiency.

11. Having a severe infection within 4 weeks before the first use of the investigational drug.

12. 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.

13. Active pulmonary tuberculosis infection detected by medical history or CT examination.

14. Having active tuberculosis, hepatitis B, or hepatitis C.

15. Having been diagnosed with any other malignant tumor within 5 years before the first use of the investigational drug.

16. Uncontrolled concurrent diseases listed in the protocol.

17. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weihua Wang, Doctor

Role: STUDY_DIRECTOR

Medical Director

Locations

Guangdong Provicial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Zhang, Master

Role: CONTACT

ying_zhang2@junshipharma.com

18616904609

Huiyu Lan, Master

Role: CONTACT

huiyu_lan@junshipharma.com

15000239047

Facility Contacts

Yilong Wu, Ph.D

Role: primary

syylwu@live.cn

020-83525210

Other Identifiers

JS207-002-II-NSCLC

Identifier Type: -

Identifier Source: org_study_id