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A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02)

StatusActive, Not Recruiting
PhasePhase 3
Started2024-05-17
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Identification, Study Status v8
Study title+14 characters
[...] nced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02)
2026-04-07
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-05→2026-12
Completion date2026-05→2026-12
Enrollment targetestimated 680→confirmed 698
Study sitesdetails revised at 1 of 1 site
2025-04-30
Study Status, Arms and Interventions v6
Re-verified, no change to tracked fields
2025-04-08
Study Status, Study Design v5
Enrollment target604→680
2024-09-24
Study Status, Study Design v4
Enrollment target548→604
Show 3 earlier versions
2024-07-17
Study Status, Study Design, Outcome Measures v3
Enrollment target558→548
Secondary endpoints5 to 6 entries
Progression-free survival (PFS)
Primary endpoints2 to 1 entries
Progression-free survival (PFS)
2024-06-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-05→confirmed 2024-05-17
Study sitesdetails revised at 1 of 1 site
2024-05-11
Study Status v1
Re-verified, no change to tracked fields
2024-04-19
Original filing
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy.
Trial Details
NCT Number NCT06382129
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 698 participants
Start Date 2024-05-17
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-17