SSGJ-707 in Advanced Non-Small Cell Lung Cancer
ConditionAdvanced Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SSGJ-707
- Pembrolizumab
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov