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)

NCT07642024 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-319
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pathologic complete response (pCR)

  Up to approximately 24 months

• Event-Free Survival (EFS)

  Up to approximately 24 months

• Overall Survival (OS)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Anti-drug antibody (ADA)

  Up to approximately 24 months

Study Arms (3)

BL-B01D1+Osimertinib

EXPERIMENTAL

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; Drug: Osimertinib

Osimertinib

ACTIVE COMPARATOR

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

Carboplatin + Pemetrexed or Cisplatin + Pemetrexed

ACTIVE COMPARATOR

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: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1+Osimertinib

Osimertinib DRUG

Oral administration for a cycle of 3 weeks.

BL-B01D1+Osimertinib; Osimertinib

Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Carboplatin + Pemetrexed or Cisplatin + Pemetrexed

Pemetrexed DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Carboplatin + Pemetrexed or Cisplatin + Pemetrexed

Cisplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Carboplatin + Pemetrexed or Cisplatin + Pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• One of the EGFR sensitive mutation types detected in the tumor tissue;
• Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
• Undergo pulmonary function testing within 28 days prior to the first dose;
• ECOG performance status score of 0 or 1;
• No severe cardiac dysfunction;
• Organ function levels must meet the required criteria;
• Urine protein ≤1+ or \<1000 mg/24h;
• 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.

You may not qualify if:

• 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;
• Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;
• Receiving long-term systemic corticosteroid therapy with prednisone \>10 mg/day within 2 weeks prior to randomization, among others;
• History of severe heart disease or cerebrovascular disease;
• Prolonged QTc interval, complete left bundle branch block, etc.;
• Any thrombotic event within 6 months prior to screening;
• Trial participants with known or suspected interstitial lung disease, among others;
• Diagnosis of active malignant tumors within 5 years prior to study randomization;
• Hypertension inadequately controlled by two antihypertensive medications;
• Trial participants with poorly controlled blood glucose;
• Severe infection occurring within 4 weeks prior to study randomization, among others;
• Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Carboplatin; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (2)