Clinical trial NCT06924606: Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy
Official title: A Phase II Clinical Study of JS207 (PD-1/VEGF Dual Antibody) Combined With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer After Progression Following Platinum-based Chemotherapy and Immunotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced NSCLC
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-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


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. Patients with incurable locally advanced or metastatic or recurrent NSCLC who have experienced treatment failure with first-line treatment using a PD-1/PD-L1 inhibitor combined with platinum-based doublet chemotherapy (except docetaxel) or treatment failure with sequential first-line treatment using a PD-1/PD-L1 inhibitor and platinum-based doublet chemotherapy (except docetaxel) may be eligible. Previous treatments include anti-VEGF monoclonal antibody. For patients with operable early stage or locally advanced NSCLC who have received adjuvant and/or neoadjuvant therapy, radical radiotherapy or radiochemotherapy, disease progression or recurrence within 6 months after the last anti-tumor therapy, adjuvant/neoadjuvant/radiochemotherapy is considered as first-line therapy.
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 (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) component.
2. Sensitivity mutation of EGFR or ALK fusion; known ROS1 fusion, BRAF V600E mutation, MET 14 exon skip mutation, RET fusion, etc. Gene mutation. The EGFR and ALK fusion status must be tested in patients with non-squamous cell carcinoma (the mutation status must be confirmed based on the tissue test if the blood test is negative); the genetic test is not mandatory for patients with squamous cell carcinoma.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 1.5years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 2years
measure: Duration of response (DOR)
timeFrame: 2years
measure: Progression-free survival (PFS)
timeFrame: 1.5years
measure: Overall survival (OS)
timeFrame: 2years
measure: AE
timeFrame: 2years
measure: Abnormal changes in laboratory
timeFrame: 2years
Other outcomes:
measure: the trough concentrations (PK)
timeFrame: 1.5years
measure: Neutralizing antibody(Nab)
timeFrame: 1.5years
measure: Antidrug antibodies (ADA)
timeFrame: 1.5years
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Jilin
country: China
facility: Jilin Cancer Hospital
state: Changchun
city: Hunan
country: China
facility: Hunan Cancer Hospital
state: Changsha
city: Sichuan
country: China
facility: West China Hospital, Sichuan University
state: Chengdu
city: Chongqing
country: China
facility: Second Affiliated Hospital, PLA Academy of Military Medical Sciences
state: Chongqing
city: Chongqing
country: China
facility: Army Medical Center, PLA
state: Chongqing
city: Guangdong
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangzhou
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
state: Hangzhou
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
state: Harbin
city: Jiangxi
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Nanchang
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: