Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy

Phase 2

Not yet recruiting

• Conditions: Advanced NSCLC
• Interventions: Drug: JS207 injection

• Registration Number: NCT06924606
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Study First Posted: 2025-04-11
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Study Start: 2025-05-15
• Primary Completion: 2026-09-26
• Study Completion: 2026-09-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS207combined with docetaxel	JS207 injection	Patients receive JS207 10mg/kg or 15mg/kg or other dosage and docetaxel 75mg/m2, q3w

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	2years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Duration of response (DOR)	2years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Progression-free survival (PFS)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Overall survival (OS)	2years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)
AE	2years	Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance
Abnormal changes in laboratory	2years	Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance

Trial Locations

Locations (12)

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Jilin Cancer Hospital; 🇨🇳 Jilin, 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, China

Army Medical Center, PLA; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangdong, Guangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Zhejiang, Hangzhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Heilongjiang, Harbin, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Jiangxi, Nanchang, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China