SSGJ-707 in Advanced Non-Small Cell Lung Cancer

Recruiting now · Phase 3

Conditions studied: Advanced Non-Small Cell Lung Cancer

In brief

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%.

Key facts

Study ID

NCT06980272

Run by

Shenyang Sunshine Pharmaceutical Co., LTD.

People needed

420

Starts

2025-06-20

Expected to finish

2028-12-31

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Shanghai East Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.