SSGJ-707 in Advanced Non-Small Cell Lung Cancer

Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Study ID
NCT06980272
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SSGJ-707 — DRUG
    Subjects receive SSGJ-707 intravenously.
  • Pembrolizumab — DRUG
    Subjects receive Pembrolizumab intravenously.

Study Details

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%.

Key Dates

Start date
Jun 20, 2025
Status verified
May 2025
Primary completion
Jul 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SSGJ-707
    Subjects receive SSGJ-707 monotherapy intravenously (IV), selected dose.
  • Active Comparator: Pembrolizumab
    Subjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.

Primary Outcome Measure

PFS assessed by IRRC per RECIST v1.1 [ Time Frame: Up to 2 approximately years ]

Central Contacts

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