Henlius starts recruiting HLX43-serplulimab trial in advanced lung cancer
The Phase 2 study opens enrollment testing an antibody-drug conjugate paired with a PD-1 inhibitor in previously treated lung cancer, part of a five-trial HLX43 program.
Executive Summary
- A Phase 2 trial pairing Henlius's antibody-drug conjugate with its PD-1 inhibitor moved into active recruitment on schedule, with enrollment plans unchanged from the original target.
- The trial tests whether the combination produces tumor responses that clear what previously treated lung cancer patients already refractory to checkpoint blockade can achieve on retreatment, feeding directly into how the asset is positioned across Henlius's broader lung cancer program.
- Henlius is one of several sponsors running PD-L1-targeted therapies in lung cancer, and the field's pace of new trial starts has slowed, sharpening the bar for any readout to stand out.
- Henlius's trial portfolio shows a completion track record well above its termination rate, supporting some confidence in this program advancing to a readout rather than stalling.
The status change
The trial, registered as NCT07253142, shifted its ClinicalTrials.gov status from Not yet recruiting to Recruiting on July 21, 2026, with a start date recorded as February 5, 2026. The study targets 120 patients with locally advanced or metastatic non-small cell lung cancer without an actionable gene alteration, or small cell lung cancer, who have progressed after platinum-based chemotherapy plus an anti-PD-1/L1 antibody in the second or third line. Its primary endpoint is objective response rate by investigator assessment within 24 weeks, with overall survival and progression-free survival tracked as secondary measures. The primary completion date is set for June 18, 2027. NCT07253142A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung CancerNCT07253142
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
Trial health
The enrollment target held steady at 120 patients with no increase or cut recorded against the anticipated figure, a change the trial's own operational model flags only at moves of 20% or more. Protocol history shows a single eligibility-criteria amendment since the study was first submitted in November 2025, and the registry's own change-frequency measure rates the trial Stable. No results have posted yet, consistent with a trial that only began recruiting this year. NCT07253142A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung CancerNCT07253142
Program context
HLX43 is being tested in five active trials sponsored by Henlius across lung cancer settings, including a Phase 2/3 study against docetaxel in squamous NSCLC and a Phase 1b/2 combination study with serplulimab in tumors, none terminated. This recruiting trial sits in the second- and third-line combination arm of that portfolio, testing the same antibody-drug conjugate paired with Henlius's own PD-1 inhibitor rather than a chemotherapy comparator. NCT07459751+1NCT07459751NCT06848699
Competitive landscape
PD-L1-targeted therapy remains an active but decelerating field in lung cancer: recent trial starts run at roughly 13% of the pace of the older cohort that built the mechanism's evidence base, and median enrollment in comparable indication-and-phase trials stretches to 2,034 days. Three direct comparators share PD-L1 targeting in adjacent tumor types: Akeso's cadonilimab in a Phase 3 colon cancer trial, Regeneron's REGN4336 in a Phase 1/2 prostate cancer study, and Exelixis's zanzalintinib in a Phase 1 tumor trial, none in lung cancer specifically. Within lung cancer, established PD-L1 and PD-1 antibodies including durvalumab and pembrolizumab are already positioned in earlier treatment lines, so a combination regimen entering after second- or third-line failure would need an objective response rate that clears what patients already refractory to checkpoint blockade can achieve on retreatment. NCT07253142A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung CancerNCT07253142
Sponsor track record
Henlius has completed 28 of 30 trials tracked across its global portfolio, with two terminated, a completion rate that supports the likelihood this study advances through to its June 2027 primary completion date rather than stalling early.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.