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A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

StatusRecruiting
PhasePhase 3
Started2025-02-24
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Identification, Study Status v5
Study title+14 characters
[...] ed Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)
2025-09-23
Study Status, Study Design v4
Enrollment target696→720
2025-04-30
Study Status, Arms and Interventions v3
InterventionsBL-B01D1 and Osimertinib (Drug), Osimertinib (Drug)→BL-B01D1 (Drug), Osimertinib (Drug), Osimertinib (Drug)
2025-03-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03→confirmed 2025-02-24
Study sitesdetails revised at 1 of 1 site
2025-02-19
Study Status, Arms and Interventions v1
InterventionsBL-B01D1 (Drug), Osimertinib (Drug)→BL-B01D1 and Osimertinib (Drug), Osimertinib (Drug)
2025-02-16
Original filing
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.
Trial Details
NCT Number NCT06838273
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 720 participants
Start Date 2025-02-24
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-20