NCT06980272 SSGJ-707 in Advanced Non-Small Cell Lung Cancer

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: 1. Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF). 2. At least 18 years of age at the time of signing the ICF, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. 4. Life expectancy of at least 12 weeks. 5. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 6. No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC. 7. At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria. Exclusion Criteria: 1. Presence of small cell carcinoma components in histological pathology. 2. Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC. 3. Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC. 4. Presence of brainstem, l

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