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A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)

StatusActive, Not Recruiting
PhasePhase 3
Started2024-05-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 23, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later May 2026 → Aug 2026
See other at-risk trials from Sichuan Baili Pharmaceutical Co., Ltd.

Amendment history

2026-07-22
Study Status v6
Primary completion pushed: 2026-05 → 2026-08
Completion pushed: 2026-05 → 2027-12
2026-04-15
Study Identification, Study Status, Contacts/Locations v5
Study title+14 characters
[...] th Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)
2025-11-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 428→confirmed 432
Study sitesdetails revised at 1 of 1 site
2025-04-30
Study Status, Arms and Interventions v3
Re-verified, no change to tracked fields
2024-05-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-05→confirmed 2024-05-22
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 non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.
Trial Details
NCT Number NCT06382116
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 432 participants
Start Date 2024-05-22
Primary Completion 2026-08 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-23