RecruitingPhase 2NCT06951464

A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC

A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer


Sponsor

Sichuan University

Enrollment

40 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Summary

This is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — BL-B01D1 (an antibody-drug conjugate) and almonertinib (a targeted therapy) — given before surgery in patients with non-small cell lung cancer (NSCLC) that has a specific genetic change called an EGFR mutation. The goal is to shrink the tumor before surgical removal and improve long-term outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage II to IIIB non-small cell lung cancer with an EGFR mutation (a specific gene change that makes your cancer sensitive to targeted drugs) - Your cancer is potentially removable by surgery after pre-treatment (neoadjuvant therapy) - Your heart and lung function are adequate - Your blood counts and organ function meet required thresholds **You may NOT be eligible if...** - Your cancer does not have the EGFR mutation - Your cancer has spread beyond the lung to distant sites - You have significant heart problems (ejection fraction below 50%) - You have previously received surgery-targeting or EGFR-targeted treatment for this cancer 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

BL-B01D1 (2.2 or 2.5mg/kg) to be administered on Day 1 and Day 8 of every 3-week cycle for 2 cycles.

DRUGAlmonertinib

Almonertinib 100mg QD


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06951464