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)

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: BL-B01D1; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Osimertinib

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Peng Zhang
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai East Hospital
      • Contact: Caicun Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign informed consent and agree to comply with the protocol requirements;
2. Aged ≥18 years and ≤75 years, regardless of gender;
3. Expected survival time ≥3 months;
4. Patients with non-small cell lung cancer;
5. One of the EGFR sensitive mutation types detected in the tumor tissue;
6. Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
7. Undergo pulmonary function testing within 28 days prior to the first dose;
8. ECOG performance status score of 0 or 1;
9. No severe cardiac dysfunction;
10. Organ function levels must meet the required criteria;
11. Urine protein ≤1+ or <1000 mg/24h;
12. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

Exclusion Criteria:

1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
2. Trial participants who subsequently receive only segmentectomy or wedge resection;
3. Trial participants deemed surgically inoperable by the study center's surgical evaluation;
4. Undergoing major surgery within 4 weeks prior to the first dose, among others;
5. Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;
6. Receiving long-term systemic corticosteroid therapy with prednisone >10 mg/day within 2 weeks prior to randomization, among others;
7. History of severe heart disease or cerebrovascular disease;
8. Prolonged QTc interval, complete left bundle branch block, etc.;
9. Any thrombotic event within 6 months prior to screening;
10. Trial participants with known or suspected interstitial lung disease, among others;
11. Diagnosis of active malignant tumors within 5 years prior to study randomization;
12. Hypertension inadequately controlled by two antihypertensive medications;
13. Trial participants with poorly controlled blood glucose;
14. Severe infection occurring within 4 weeks prior to study randomization, among others;
15. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
16. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
17. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
19. Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.;
20. History of allergy to the investigational drug, etc.;
21. History of solid organ transplantation, autologous or allogeneic stem cell transplantation;
22. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
23. History of severe neurological or psychiatric disorders;
24. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;
25. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: BL-B01D1; Administration by intravenous infusion for a cycle of 3 weeks.; Other Names: BMS-986507; iza-bren; izalontamab brengitecan; Drug: Osimertinib; Oral administration for a cycle of 3 weeks.
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.	Drug: Osimertinib; Oral administration for a cycle of 3 weeks.
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.	Drug: Pemetrexed; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Carboplatin; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Cisplatin; Administration by intravenous infusion for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathological Response (MPR)	MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection.	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.	Up to approximately 24 months
Anti-drug antibody (ADA)	Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.	Up to approximately 24 months
Overall Survival (OS)	Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.	Up to approximately 24 months
Pathologic complete response (pCR)	pCR is defined as the absence of any residual tumor (lesions) in the primary tumor upon surgical resection.	Up to approximately 24 months
Event-Free Survival (EFS)	EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; osimertinib
• Other Study ID Numbers: BL-B01D1-319

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No