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)

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT06838273
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Osimertinib — DRUG
    Oral administration, 80mg daily for a cycle of 3 weeks.
  • Osimertinib — DRUG
    Oral administration, 80mg daily for a cycle of 3 weeks.

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
720 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1 in Combination with Osimertinib
    Participants receive BL-B01D1 in Combination with Osimertinib for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: Osimertinib
    Participants receive Osimertinib for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 36 months ]

Central Contacts

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