A Phase 2 interventional study of SSGJ-706 and SPGL008 in Non Small Cell Lung Cancer, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. (part of 3SBio Inc.) · Phase 2, Interventional, and Treatment
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small cell lung cancer.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 220 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 40 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Biological: SSGJ-706 · Biological: SPGL008
Biological: SSGJ-706 · Biological: SPGL008
Biological: SSGJ-706 · Biological: SPGL008 · Drug: Chemotherapy
SSGJ-706 is a bispecific antibody that targets both human PD-1 and PD-L1
SPGL008 is a dual-functional molecule that combines an anti-B7-H3 monoclonal antibody with IL-15Rα sushi / IL-15.
Chemotherapy
Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0
Collect and analyze the incidence of adverse events to evaluate safety and tolerability per NCI-CTCAE v6.0
Time frame: 24 months
Objective Response Rate(ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame: 24 months
Maximum Plasma Concentration (Cmax)
Collect blood samples at the preset time points, measure the concentrations, draw the concentration-time curve, and select the highest point on the curve.
Time frame: 24 months
Area under the curve (AUC)
Based on the concentrations at multiple time points and the time
Time frame: 24months
Half-life (T1/2)
Calculate the half-life based on the concentration of the collected data.
Time frame: 24months
Lymphocytes
Calculate and analyze the relationship between lymphocytes and efficacy
Time frame: 24months
Immunogenicity
Subjects will be tested for anti-drug antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
Time frame: 24months
Cytokines
Calculate and analyze the relationship between cytokines and efficacy
Time frame: 24months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Shenyang Sunshine Pharmaceutical Co., LTD. →