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

NCT ID: NCT06951464

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2029-03-05

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BL-B01D1 plus Almonertinib

Neoadjuvant BL-B01D1 2.2 or 2.5mg/kg D1D8 Q3W plus Almonertinib 100mg QD

Group Type: EXPERIMENTAL

BL-B01D1

Intervention Type: DRUG

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.

Almonertinib

Intervention Type: DRUG

Almonertinib 100mg QD

Interventions

BL-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.

Intervention Type: DRUG

Almonertinib

Almonertinib 100mg QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form and comply with the study protocol requirements.

2. Male or female, Age ≥18 years and ≤75 years at the time of signing the informed consent form.

3. Diagnosed with stage II-IIIB (according to Version 8 of TNM staging) EGFR-sensitive mutation-positive non-small cell lung cancer (NSCLC) with feasibility or potential feasibility for radical surgery (radical lobectomy + systematic lymph node dissection), and assessed by the investigator as requiring neoadjuvant therapy.

4. Adequate pulmonary function to tolerate surgery.

5. Must have at least one measurable lesion per RECIST v1.1 criteria.

6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1.

7. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%.

8. Organ function levels must meet the following criteria:

1. Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;

2. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN, AST and ALT ≤2.5×ULN;

3. Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula);

4. Albumin ≥30 g/L.

9. Coagulation function: International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN.

10. Urine protein: ≤2+ on dipstick or ≤1000 mg/24h.

11. Contraception: Females of childbearing potential or males with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 6 months after the last dose. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.

Exclusion Criteria

1. Patients who have received previous systemic or local anti-tumor therapy for non-small-cell lung cancer.

2. Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment.

3. Major surgery (investigator-defined) within 4 weeks before the first dose.

4. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.

5. Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications.

6. Patients at risk for active autoimmune disease, or with a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes mellitus, hypothyroidism that is stable with hormone-replacement therapy (including that due to autoimmune thyroiditis), psoriasis or vitiligo that does not require systemic treatment, and hypothyroidism that is stable with hormone-replacement therapy.

7. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA copy number > central detection lower limit) or hepatitis C virus infection (HCV antibody positive and HCV-RNA> central detection lower limit).

8. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg).

9. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:

1. severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, complete left bundle branch block, frequent and uncontrollable arrhythmias, such as atrial fibrillation, atrial flutter, ventricular fibrillation, and ventricular flutter (except transient); h) prolonged QT interval (QTc>450 msec in men or QTc>470 msec in women) at rest (except transient);

2. acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular or cerebrovascular event occurring within 6 months before the first dose;

3. patients with New York Heart Association (NYHA) functional class ≥II heart failure;

4. unstable angina pectoris;

5. Patients with a history of cerebral infarction or cerebral hemorrhage within 6 months;

10. Previous history of allogeneic stem cell, bone marrow or organ transplantation.

11. Patients with a history of allergy to recombinant humanized antibodies or to BL-B01D1 or any excipients of Almonertinib Mesylate Tablets.

12. A history of autologous or allogeneic stem cell transplantation.

13. Pregnant or lactating women.

14. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Yongsheng Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongsheng Wang

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Lunxu Liu

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Chen, PhD

Role: CONTACT

cy9209@163.com

86（028）85421606

Facility Contacts

Yue Chen

Role: primary

cy9209@163.com

8602885421606

Other Identifiers

BL-B01D1-206

Identifier Type: -

Identifier Source: org_study_id