RecruitingPhase 3NCT06838273

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)

A Phase III Randomized 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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

720 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a combination of BL-B01D1 — a new antibody-drug conjugate targeting cancer proteins EGFR and HER3 — plus osimertinib versus osimertinib alone as first-line treatment for people with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are 18 or older with locally advanced or metastatic NSCLC that cannot be removed surgically or treated with radical radiation - Your tumor has a known EGFR-sensitizing mutation (confirmed by tumor or blood testing) - You have at least one measurable tumor on imaging - You have a good performance status (ECOG 0 or 1) - You have not received prior systemic treatment for advanced disease **You may NOT be eligible if...** - You have had prior EGFR-targeted therapy or other systemic treatment for advanced NSCLC - You have uncontrolled brain metastases - You have significant heart, lung, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGOsimertinib

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

DRUGOsimertinib

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


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06838273


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