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A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

StatusRecruiting
PhasePhase 2
Started2025-06-09
View on ClinicalTrials.gov ↗

Amendment history

2025-08-12
Study Status, Arms and Interventions, Contacts/Locations v4
InterventionsHLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug)→HLX43 DOSE 1 (2.0 mg/kg) (Drug), HLX43 DOSE 2 (2.5 mg/kg) (Drug)
2025-07-03
Study Status, Sponsor/Collaborators, Eligibility v3
Eligibility criteria+234 characters
[...] ystem (8th edition), and should meet the following criteria: 1) Subjects without actionable genomic alterations (AGAs): Subjects with non-squamous NSCLC must have documented negative test results for EGFR and ALK alterations. If no prior test results for EGFR and ALK are available, subjects must undergo EGFR and ALK testing at the study site. For subjects with squamous NSCLC, EGFR and/or ALK testing is not required p [...] Prior standard treatment failure of ≥ 1 line, including at least anti-PD-(L)1 antibody and platinum-based chemotherapy; 2) Subjects with AGAs: Previous test results confirming the [...] [...]
Collaborators1 entry, revised
Henlius USA Inc.
2025-06-09
Study Status v2
Start dateestimated 2025-05-28→confirmed 2025-06-09
2025-04-24
Study Identification, Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v1
Start date2025-05-26→2025-05-28
Study sites1→2
Eligibility criteria-103 characters
Inclusion Criteria: 1. Have a full understanding of the study content, process, and [...] be able to complete the study as per protocol requirements; 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histologically or cytologically confirmed, locally advanced [...] ystem (8th edition), and should meet the following criteria: 1)Subjects without actionable genomic alterations (AGAs): · Prior standard treatment failure, including at least PD-(L)1 and platinum-based chemotherapy; 2) Subjects with AGAs: Prior standard treatment failure, includ [...] eated with EGFR inhibitors) and platinum-based [...]
Collaborators+11 characters
Henlius USA
Study title+1 characters
APhaseA Phase II Clinical Study to Evaluate HLX43 in Subjects withWith Advanced Non-small Cell Lung Cancer (NSCLC)
2025-03-26
Original filing
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)
Trial Details
NCT Number NCT06907615
Lead Sponsor Shanghai Henlius Biotech
Collaborators: Henlius USA Inc.
Conditions Non Small Cell Lung Cancer
Enrollment 243 participants
Start Date 2025-06-09
Primary Completion 2028-04-20 (estimated)
Study Completion 2028-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-10-01