Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS207 injection +docetaxel, JS207 injection +JS004 injection, JS207 injection.
- Who it may be relevant to
- Registry conditions: Advanced NSCLC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
Interventions
- Drug JS207 injection +docetaxel
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w. - Drug JS207 injection +JS004 injection
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w. - Drug JS207 injection
Patients receive JS207 10mg/kg or other dosage.
Primary outcome measures
- Objective response rate (ORR) [Time frame: 1.5years]
Secondary outcome measures (6)
- Disease control rate (DCR) [Time frame: 2years]
- Duration of response (DOR) [Time frame: 2years]
- Progression-free survival (PFS) [Time frame: 1.5years]
- Overall survival (OS) [Time frame: 2years]
- AE [Time frame: 2years]
- Abnormal changes in laboratory [Time frame: 2years]
Eligibility criteria
Inclusion criteria
- 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.
- 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).
- Subjects must have at least one measurable lesion according to RECIST v1.1.
Exclusion criteria
- Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
- Sensitivity mutation of EGFR or ALK fusion.
- Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 18 centers
- Beijing Chest Hospital, Capital Medical University — Beijing
- Jilin Cancer Hospital — Jilin City
- Hunan Cancer Hospital — Hunan
- West China Hospital, Sichuan University — Sichuan
- Second Affiliated Hospital, PLA Academy of Military Medical Sciences — Chongqing
- Army Medical Center, PLA — Chongqing
- The First Affiliated Hospital of Guangzhou Medical University — Guangdong
- Harbin Medical University Cancer Hospital — Heilongjiang
- … and 10 more centers
Identifiers
NCT: NCT06924606 · JS207-004-II-NSCLC