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)

Phase 3 Recruiting 720 enrolled Sichuan Baili Pharmaceutical Co., Ltd. Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2025-02-24
Primary completion: 2028-12
Completion: 2028-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Izalontamab Brengitecan	Unknown	—	Intravenous
Comparator	Osimertinib	Small molecule	80 mg	Oral

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)

Summary

Timeline

Drugs

Indications