{"entity":{"id":"nct07318883","kind":"trial","name":"A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab","aka":[],"tldr":"A phase 2/3 trial of serplulimab, pembrolizumab and carboplatin in lung cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer is a phase 2/3, randomised interventional study registered as NCT07318883 by Shanghai Henlius Biotech, with a registry enrolment figure of 720 participants, started 2026-03 and due to reach its primary completion in 2031-01. Interventions recorded: HLX07; HLX07 placebo; Serplulimab; Pembrolizumab; Carboplatin; Paclitaxel or Nab-Paclitaxel. Conditions listed: Squamous NSCLC. Primary outcome: ORR assessed by BICR (part I); PFS assessed by BICR (part I); PFS assessed by BICR (part II). Lung eligibility wording from the registry: \"Histologically confirmed with stage IIIB/IIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT07318883","url":"https://clinicaltrials.gov/study/NCT07318883"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["egfr-mutant-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["serplulimab","pembrolizumab","carboplatin"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07318883","phase":"2/3","setting":"A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)","sponsor":"Shanghai Henlius Biotech","enrolled":720,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07318883/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"serplulimab","kind":"drug","name":"Serplulimab","route":"/drugs/serplulimab/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}],"term":[{"id":"lung-trials-open-today","kind":"term","name":"Lung cancer trials open today (registry snapshot)","route":"/terms/lung-trials-open-today/"}]}}