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)

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07642024
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Osimertinib — DRUG
    Oral administration for a cycle of 3 weeks.
  • Carboplatin — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Pemetrexed — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Cisplatin — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Jul 24, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2032

Study Design

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

Arms

  • Experimental: BL-B01D1+Osimertinib
    Participants receive BL-B01D1+Osimertinib in 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 in 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: Carboplatin + Pemetrexed or Cisplatin + Pemetrexed
    Participants receive Carboplatin + Pemetrexed or Cisplatin + Pemetrexed in 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

Major Pathological Response (MPR) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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