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)

NCT06838273 | Recruiting Phase 3 DMC

• 1 other identifier: BL-B01D1-308
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 36 months

Secondary Outcomes (6)

• Overall survival (OS)

  Up to approximately 36 months

• Objective Response Rate (ORR)

  Up to approximately 36 months

• Disease Control Rate (DCR)

  Up to approximately 36 months

• Duration of Response (DOR)

  Up to approximately 36 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 36 months

Study Arms (2)

BL-B01D1 in Combination with Osimertinib

EXPERIMENTAL

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.

Drug: BL-B01D1; Drug: Osimertinib

Osimertinib

ACTIVE COMPARATOR

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.

Drug: Osimertinib

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 in Combination with Osimertinib

Osimertinib DRUG

Oral administration, 80mg daily for a cycle of 3 weeks.

BL-B01D1 in Combination with Osimertinib

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Age ≥18 years old;
• Expected survival time ≥3 months;
• Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;
• Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
• Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period;
• Urinary protein ≤2+ or \< 1000mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

You may not qualify if:

• Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;
• Patients with previous systemic therapy;
• Patients had received EGFR-TKI therapy;
• Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Were diagnosed with active malignancy within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
• Patients with poor glycemic control;
• A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system metastasis;
• Had a severe infection within 4 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)