# A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab

Source: https://onco.cc/trials/nct07318883/  
OnCo record `nct07318883` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-25
- Tags: ctgov-ingest; lung-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07318883: https://clinicaltrials.gov/study/NCT07318883

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Serplulimab](https://onco.cc/drugs/serplulimab/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- terms: [Lung cancer trials open today (registry snapshot)](https://onco.cc/terms/lung-trials-open-today/)

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