Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
Recruiting · NCT06924606 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
JS207 injectionJS207 injection +JS004 injectionJS207 injection +docetaxel
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
18 locations listed.
- Shanghai Pulmonary Hospital - Shanghai, China
- Beijing Chest Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Jilin Cancer Hospital - Jilin City, Changchun, China
- Hunan Cancer Hospital - Hunan, Changsha, China
- West China Hospital, Sichuan University - Sichuan, Chengdu, China
- Second Affiliated Hospital, PLA Academy of Military Medical Sciences - Chongqing, Chongqing Municipality, China
- Army Medical Center, PLA - Chongqing, Chongqing Municipality, China
- The First Affiliated Hospital of Guangzhou Medical University - Guangdong, Guangzhou, China
- Harbin Medical University Cancer Hospital - Heilongjiang, Harbin, China
- Anyang Tumor Hospital - Anyang, Henan, China
- The First Affiliated Hospital of Henan University of Science and Technology - Luoyang, Henan, China
- The First Affiliated Hospital of Xinxiang Medical University - Xinxiang, Henan, China
- The First People's Hospital of Changde - Changde, Hunan, China
- The First Affiliated Hospital of Nanchang University - Jiangxi, Nanchang, China
- Shanghai Pulmonary Hospital - Shanghai, Shanghai Municipality, China
- The Third People's Hospital of Datong - Datong, Shanxi, China
- Yibin Second People's Hospital - Yibin, Sichuan, China
- Affiliated Tumor Hospital of Xinjiang Medical University - Xinjiang, Xinjiang, China