RecruitingPhase 3NCT06980272

SSGJ-707 in Advanced Non-Small Cell Lung Cancer

A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer


Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Enrollment

420 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SSGJ-707 in people with advanced non-small cell lung cancer (NSCLC) who have not yet received systemic treatment. SSGJ-707 is a bispecific antibody — it targets two proteins at once (PD-1 and VEGF) to help the immune system attack cancer while also cutting off its blood supply. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of locally advanced or metastatic (stage IIIB–IV) NSCLC - You have not yet received any systemic treatment for your advanced lung cancer - You are in good physical condition (able to care for yourself and perform daily activities) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your lung cancer has a specific genetic mutation (such as EGFR, ALK, BRAF, MET, NTRK, RET, or ROS1) - Your cancer includes small cell components - You have active brain, spinal cord, or leptomeningeal metastases - You have HIV, active tuberculosis, or history of organ/stem cell transplant - You have unresolved side effects from prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSSGJ-707

Subjects receive SSGJ-707 intravenously.

DRUGPembrolizumab

Subjects receive Pembrolizumab intravenously.


Locations(1)

The Shanghai East Hospital

Shanghai, China

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NCT06980272


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