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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SSGJ-707
DrugSubjects receive SSGJ-707 intravenously.
Pembrolizumab
DrugSubjects receive Pembrolizumab intravenously.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: SSGJ-707Experimental treatment 1 intervention
Group B: PembrolizumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PFS assessed by IRRC per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Time frame
Up to 2 approximately yearsSecondary outcomes
1
OS
Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-707 until death due to any cause.
Time frame
Up to 2 approximately years2
ORR assessed by IRRC per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame
Up to 2 approximately years3
DoR assessed by IRRC per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame
Up to 2 approximately years4
DCR assessed by IRRC per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame
Up to 2 approximately yearsSponsors and contacts
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Source ClinicalTrials.gov