A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07622186
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SKB571 for injection — DRUG
    Intravenous(IV) infusion(Q3W)
  • Osimertinib — DRUG
    orally once daily
  • Furmonertinib — DRUG
    orally once daily
  • carboplatin — DRUG
    Intravenous(IV) infusion(Q3W)
  • Cisplatin — DRUG
    Intravenous(IV) infusion(Q3W)
  • Pembrolizumab — DRUG
    Intravenous(IV) infusion(Q3W)

Study Details

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Key Dates

First listed
Jun 3, 2026
Start date
Jul 15, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NSCLC with sensitive EGFR mutations
  • Experimental: NSCLC with EGFR wild-type
  • Experimental: NSCLC with uncommon EGFR mutations

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to approximately 36 months ]

Central Contacts

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