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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Sign the informed consent form voluntarily and follow the protocol requirements;

Age ≥18 years old;

Expected survival time ≥3 months;

Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;

Disqualifiers

Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;

Patients with previous systemic therapy;

Patients had received EGFR-TKI therapy;

Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • Osimertinib
  • Osimertinib

Treatment groups

720 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator