Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2025-06-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SSGJ-707
Subjects receive SSGJ-707 monotherapy intravenously (IV), selected dose.
SSGJ-707
Subjects receive SSGJ-707 intravenously.
Pembrolizumab
Subjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.
Pembrolizumab
Subjects receive Pembrolizumab intravenously.
Interventions
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SSGJ-707
Subjects receive SSGJ-707 intravenously.
Pembrolizumab
Subjects receive Pembrolizumab intravenously.
Eligibility Criteria
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Inclusion Criteria
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
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, leptomeningeal, spinal cord metastasis or compression.
5. Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.
6. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
7. History of immunodeficiency; positive for HIV antibodies;
8. Known active tuberculosis (TB);
9. Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
10. 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.
18 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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The Shanghai East Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-707-NSCLC-III-01
Identifier Type: -
Identifier Source: org_study_id
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