Global Phase IIIII Study Comparing HLX43 Alone or With HLX07 to Docetaxel for Advanced Squamous Non-Small Cell Lung Cancer After First-Line Treatment Failure

What this Trial Is About

Researchers are conducting a randomized, open-label, multi-center, global phase IIIII clinical trial to evaluate the safety and effectiveness of HLX43 alone or combined with HLX07 compared to docetaxel in treating advanced or metastatic squamous non-small cell lung cancer NSCLC after first-line treatment failure. This study focuses on patients with locally advanced or metastatic squamous NSCLC who have progressed after prior platinum-based chemotherapy and anti-PD-1PD-L1 therapy. Participants are assigned to one of three groups receiving intravenous treatments on Day 1 of each 3-week cycle HLX43 monotherapy, HLX43 combined with HLX07, or docetaxel as an active comparator. The study includes treatment periods with these regimens, assessing their impact over time. The trial is sponsored by Shanghai Henlius Biotech and spans multiple global centers. Throughout the study, participants undergo regular evaluations including survival assessments up to 24 months, monitoring progression-free survival, tumor response rates, duration of response, disease control rates, and adverse events. Laboratory tests, imaging, and tumor tissue analyses for PD-L1 and EGFR expression are conducted. Participants are monitored for safety and treatment adherence, with an expected life expectancy of more than three months and an ECOG performance status of 0-1 at enrollment.

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer