18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of PembrolizumabPrimary· From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 months
Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Group
Value
95% CI
HBI-8000 in Combination With Pembrolizumab
5
HBI-8000 in Combination With Pembrolizumab
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 13 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other HUYABIO International, LLC. trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HUYABIO International, LLC.
Last refreshed: 24 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05141357.