NCT07309276

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 864 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.

Detailed description

Part One: The plan involves including patients with previously failed standard treatments in advanced NSCLC and ES-SCLC. It consists of two phases: safety introduction and clinical expansion, covering cohorts 1 to 3. The safety introduction phase will explore the safety of the following combined regimens in the target population: Queue 1: JS212 + JS207 Queue 2: JS212 + Toripalimab Queue 3: JS212 + JS213 Part Two: It is planned to include lung cancer patients who have not received any systemic anti-tumor treatment for advanced NSCLC and ES-SCLC in the past. If the SMC decides to further combine chemotherapy, the safety introduction phase should also include to ensure the safety of the subjects.

Conditions

• Advanced Lung Cancer

Interventions

Type	Name	Description
DRUG	JS212 for Injection	Administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	JS207 for Injection	Administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	Toripalimab	Administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	JS213 for Injection	Administered by intravenous infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-11-30
• Completion: 2028-11-11
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China