Actively Recruiting
SSGJ-707 in Advanced Non-Small Cell Lung Cancer
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-06-24
420
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
SSGJ-707 in Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate voluntarily and complete all study procedures with signed consent
- At least 18 years old at time of consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Diagnosed with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC
- No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC
- At least one measurable tumor lesion as per RECIST v1.1 criteria
You will not qualify if you...
- Presence of small cell carcinoma components in tumor pathology
- EGFR-sensitive mutations or ALK fusion-positive NSCLC
- Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC
- Brainstem, leptomeningeal, spinal cord metastasis or compression
- Unresolved toxicity from prior anti-tumor treatment not at Grade 0 or 1
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of immunodeficiency or positive for HIV antibodies
- Known active tuberculosis
- History of severe allergy to study drug components or chimeric/humanized antibodies
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
C
Caicun Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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