Actively Recruiting
A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC
Led by Sichuan University · Updated on 2025-07-23
40
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of consent
- Diagnosis of stage II-IIIB EGFR mutation-positive non-small cell lung cancer
- Cancer must be resectable and suitable or potentially suitable for radical surgery
- Adequate lung function to tolerate surgery
- At least one measurable tumor lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate organ function including bone marrow, liver, kidney, albumin, and coagulation parameters
- Urine protein level no greater than 2+ on dipstick or 1000 mg/24h
- Use of effective contraception for females and males of childbearing potential
- Negative pregnancy test for females of childbearing potential within 7 days before first dose
You will not qualify if you...
- Previous systemic or local anti-tumor therapy for non-small cell lung cancer
- Other malignant tumors within 5 years except certain cured cancers
- Major surgery within 4 weeks before first dose
- Current or history of interstitial lung disease or radiation pneumonitis requiring steroids
- Severe systemic infection within 4 weeks before screening
- Active autoimmune disease or history of autoimmune diseases except certain stable conditions
- Positive for HIV, active tuberculosis, or active hepatitis B or C infection
- Poorly controlled high blood pressure
- Severe cardiovascular or cerebrovascular diseases within 6 months
- New York Heart Association (NYHA) class II or higher heart failure
- History of certain heart rhythm abnormalities
- History of allogeneic stem cell, bone marrow, or organ transplantation
- Allergy to recombinant humanized antibodies, BL-B01D1, or Almonertinib excipients
- Pregnant or breastfeeding women
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yue Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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