A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.

Eligibility criteria

Qualifiers

Voluntarily sign informed consent and agree to comply with the protocol requirements;

Aged ≥18 years and ≤75 years, regardless of gender;

Expected survival time ≥3 months;

Patients with non-small cell lung cancer;

Disqualifiers

SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;

Trial participants who subsequently receive only segmentectomy or wedge resection;

Trial participants deemed surgically inoperable by the study center's surgical evaluation;

Undergoing major surgery within 4 weeks prior to the first dose, among others;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • Osimertinib
  • Carboplatin
  • Pemetrexed
  • Cisplatin

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator