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

NCT06951464 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pathological complete response (pCR)

  Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery

  Approximately 9-11 weeks after the first dose

• Major Pathological Response (MPR)

  Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

  Approximately 9-11 weeks after the first dose

Secondary Outcomes (6)

• Objective Response Rate（ORR）

  Approximately 9-11 weeks after the first dose

• Event-free survival (EFS)

  From date of first administration up to approximately 5.5 years after the last patient is administrated

• Disease free survival (DFS)

  From date of first administration up to approximately 3.5 years after the last patient is administrated

• Overall Survival (OS)

  From date of first administration up to approximately 5.5 years after the last patient is administrated

• R0 resection rate

  Approximately 9-11 weeks after the first dose

Other Outcomes (1)

• Biomarker expression in tumor tissues

  From date of first administration up to approximately 5.5 years after the last patient is administrated

Study Arms (1)

BL-B01D1 plus Almonertinib

EXPERIMENTAL

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

Drug: BL-B01D1; Drug: Almonertinib

Interventions

BL-B01D1 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.

BL-B01D1 plus Almonertinib

Almonertinib DRUG

Almonertinib 100mg QD

BL-B01D1 plus Almonertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the study protocol requirements.
• Male or female, Age ≥18 years and ≤75 years at the time of signing the informed consent form.
• 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.
• Adequate pulmonary function to tolerate surgery.
• Must have at least one measurable lesion per RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1.
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%.
• Organ function levels must meet the following criteria:
• Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
• Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN, AST and ALT ≤2.5×ULN;
• Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50 mL/min (calculated by Cockcroft-Gault formula);
• Albumin ≥30 g/L.
• Coagulation function: International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN.
• Urine protein: ≤2+ on dipstick or ≤1000 mg/24h.
• 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.

You may not qualify if:

• Patients who have received previous systemic or local anti-tumor therapy for non-small-cell lung cancer.
• 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.
• Major surgery (investigator-defined) within 4 weeks before the first dose.
• Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.
• 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.
• 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.
• 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).
• Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg).
• A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
• 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);
• 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;
• patients with New York Heart Association (NYHA) functional class ≥II heart failure;
• unstable angina pectoris;
• Patients with a history of cerebral infarction or cerebral hemorrhage within 6 months;
• Previous history of allogeneic stem cell, bone marrow or organ transplantation.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

• Chen Y, Mei J, Gao G, Zhang B, Li Y, Peng Z, Li C, Gan F, Pu Q, Liu C, Yang W, Liu L, Wang Y. A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. Transl Lung Cancer Res. 2025 Dec 31;14(12):5527-5534. doi: 10.21037/tlcr-2025-829. Epub 2025 Dec 17.

  PMID: 41510386 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Yongsheng Wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Lunxu Liu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Chen, PhD

CONTACT

86（028）85421606; cy9209@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): March 5, 2029
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)