JS207 for advanced non-small cell lung cancer after platinum chemo and immunotherapy

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 trial will test JS207 — alone or combined with docetaxel or JS004 — to see if it is safe and helps people with advanced non-small cell lung cancer whose disease progressed after platinum-based chemotherapy and PD-1/PD-L1 immunotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 18 sites (Beijing, Beijing Municipality and 17 other locations)
• Trial ID: NCT06924606 on ClinicalTrials.gov

What this trial studies

This open-label, multi-arm Phase II trial enrolls people with unresectable locally advanced, metastatic, or recurrent NSCLC who have progressed after PD‑1/PD‑L1 inhibitors combined with platinum-based doublet chemotherapy. Participants are allocated to one of three arms: JS207 alone, JS207 plus docetaxel, or JS207 plus JS004. The study monitors safety, tolerability, and preliminary anti-tumor activity using RECIST v1.1 measurable lesions. Findings will guide whether JS207 regimens should proceed to larger trials.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable locally advanced, metastatic, or recurrent NSCLC who progressed after PD‑1/PD‑L1 therapy plus platinum-based doublet chemotherapy (excluding prior docetaxel) and who have at least one RECIST v1.1-measurable lesion without EGFR sensitizing mutations or ALK fusions.

Not a fit: Patients with EGFR mutations or ALK fusions, tumors with a combined neuroendocrine component, tumors encircling major blood vessels with high bleeding risk, or those who have not received the specified prior chemo‑immunotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, JS207 could provide a new treatment option that slows tumor growth or extends survival for patients whose NSCLC progressed after standard chemo-immunotherapy.

How similar studies have performed: Early-phase combinations of novel biologics with chemotherapy or other antibodies in NSCLC have shown mixed results, and JS207 itself remains investigational with limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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).
3. Subjects must have at least one measurable lesion according to RECIST v1.1.

Exclusion Criteria:

1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
2. Sensitivity mutation of EGFR or ALK fusion.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.

Where this trial is running

Beijing, Beijing Municipality and 17 other locations

• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Jilin Cancer Hospital — Jilin, Changchun, China (RECRUITING)
• Hunan Cancer Hospital — Hunan, Changsha, China (RECRUITING)
• West China Hospital, Sichuan University — Sichuan, Chengdu, China (RECRUITING)
• Second Affiliated Hospital, PLA Academy of Military Medical Sciences — Chongqing, Chongqing Municipality, China (RECRUITING)
• Army Medical Center, PLA — Chongqing, Chongqing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou Medical University — Guangdong, Guangzhou, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Heilongjiang, Harbin, China (RECRUITING)
• Anyang Tumor Hospital — Anyang, Henan, China (RECRUITING)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (RECRUITING)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (RECRUITING)
• The First People's Hospital of Changde — Changde, Hunan, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Jiangxi, Nanchang, China (RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• The Third People's Hospital of Datong — Datong, Shanxi, China (RECRUITING)
• Yibin Second People's Hospital — Yibin, Sichuan, China (RECRUITING)
• Affiliated Tumor Hospital of Xinjiang Medical University — Xinjiang, Xinjiang, China (RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Xiaojun Wang, Master

Conditions: Advanced NSCLC