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
Shenyang Sunshine Pharmaceutical Co., LTD.
420 participants
Jun 20, 2025
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
Inclusion Criteria7
- Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF).
- At least 18 years of age at the time of signing the ICF, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Life expectancy of at least 12 weeks.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
- No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC.
- At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.
Exclusion Criteria11
- Presence of small cell carcinoma components in histological pathology.
- Presence of 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.
- Presence of brainstem, leptomeningeal, spinal cord metastasis or compression.
- Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of immunodeficiency; positive for HIV antibodies;
- Known active tuberculosis (TB);
- Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
- Pregnant or breastfeeding women.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Interventions
Subjects receive SSGJ-707 intravenously.
Subjects receive Pembrolizumab intravenously.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06980272