JS207 combined with chemotherapy as first-line treatment for advanced non-small cell lung cancer

JS207 (PD-1/VEGF Dual Antibody) Combined With Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer

This will test whether adding the experimental drug JS207 to standard first-line platinum-based chemotherapy helps people with advanced non-small cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06969027 on ClinicalTrials.gov

What this trial studies

This phase 2, multicohort study will enroll about 60–84 patients with locally advanced, metastatic, or recurrent NSCLC who are eligible for first-line systemic therapy. Participants receive one of two arms: Arm 1 combines JS207 (10 or 15 mg/kg IV on day 1) with pemetrexed plus a platinum agent for four 3-week cycles followed by maintenance JS207 plus pemetrexed; Arm 2 combines JS207 (10 or 15 mg/kg IV on day 1) with paclitaxel plus a platinum agent for four 3-week cycles followed by maintenance JS207. Treatment continues until prespecified withdrawal criteria are met. The study requires tumor tissue for PD-L1 testing and measures safety, tolerability, and preliminary anti-tumor activity by standard imaging criteria.

Who should consider this trial

Good fit: Adults 18–75 with stage IIIB/IIIC, metastatic, or recurrent NSCLC who have not had prior systemic therapy for metastatic disease, have ECOG performance status 0–1, at least one measurable lesion, and available tumor tissue for PD-L1 testing.

Not a fit: Patients who already received systemic therapy for metastatic NSCLC, have poor performance status (ECOG >1), cannot provide tumor tissue, or have significant uncontrolled comorbidities are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combination could increase tumor response and delay disease progression compared with chemotherapy alone.

How similar studies have performed: Previous first-line trials combining immune or antibody therapies with platinum-based chemotherapy in advanced NSCLC have improved response rates and survival, so this approach builds on established successful combinations.

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-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
3. History of no systemic antitumor therapy for Metastatic or recurrent NSCLC; for subjects who have received adjuvant/neoadjuvant/consolidation therapy (Chemotherapy, radiotherapy, or other therapy), they can be enrolled if the interval between the last treatment and recurrence is more than 6 months.
4. Tissue samples are required for PD-L1 test. New tissue samples are preferred. If new tissue samples are not available, archived samples can be provided.
5. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.
6. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
7. Expected survival period ≥ 12 weeks.
8. The function of important organs meets the requirements of the protocol.
9. 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.
10. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.

Exclusion Criteria:

1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer and large cell neuroendocrine carcinoma) components.
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

Where this trial is running

Jinan, Shandong

• Shandong First Medical University Affiliated Neoplasm Hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Ying Zhang, Master

Conditions: Non-small Cell Lung Cancer