{"entity":{"id":"nct07459751","kind":"trial","name":"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","aka":[],"tldr":"A phase 2/3 trial testing HLX43 in non-small-cell lung cancer, now recruiting.","summary":"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 is a phase 2/3 interventional study registered as NCT07459751, led by Shanghai Henlius Biotech, and recruiting on the registry. Official title: A Randomised, Open-Label, Multi-centre, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC). Planned enrolment is 706 participants (estimated). The study started in 2026-05-27 and primary completion is expected in 2030-01-15. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07459751","url":"https://clinicaltrials.gov/study/NCT07459751"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx43"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07459751","phase":"2/3","setting":"A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)","sponsor":"Shanghai Henlius Biotech","participation":[{"nct":"NCT07459751","source":"https://clinicaltrials.gov/study/NCT07459751","fetchedAt":"2026-10-07T16:55:45.930Z","studySha256":"231f2a84a9ded5dfd46c3307f8fe98f574346f064e553ba0f9d061776126605e","overallStatus":"RECRUITING","lastUpdatePosted":"2026-06-01","leadSponsor":"Shanghai Henlius Biotech","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":706,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":1,"countries":["China"]}],"started":"2026-05-27","startedType":"actual","enrolled":706,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07459751/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"hlx43","kind":"drug","name":"HLX43","route":"/drugs/hlx43/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}]}}