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A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer

StatusRecruiting
PhasePhase 2
Started2026-02-05
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-14→confirmed 2026-02-05
Study sites1→10
2025-12-01
Study Status, Eligibility v1
Eligibility criteria+85 characters
Inclusion Criteria: 1. Voluntarily to participate in the trial, and be able to complete the study as required by the protocol; 2. Age ≥18 years and ≤75 years; 3. Histologically or cytologically confirmed locally advanced ( [...] atment, with evidence of disease progression or recurrence; 4. Subjects must meet the following prior treatment requirements: 1) Have received platinum-based chemotherapy combined with anti [...] atment; have received no more than second-line treatment; or 2) Have received platinum-based chemotherapy and anti-PD-1/L1 [...] test within 7 days prior to enrollment. Exclusion Criteria: 1. Mi [...] [...]
2025-11-19
Original filing
The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.
Trial Details
NCT Number NCT07253142
Lead Sponsor Shanghai Henlius Biotech
Conditions Non Small Cell Lung Cancer, Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2026-02-05
Primary Completion 2027-06-18 (estimated)
Study Completion 2028-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-21