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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Yue Chen, PhD
cy9209@163.com
86(028)85421606
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2029-03-05
Participants
Target number of participants: 40
Treatments
Experimental: BL-B01D1 plus Almonertinib
Neoadjuvant BL-B01D1 2.2 or 2.5mg/kg D1D8 Q3W plus Almonertinib 100mg QD
Sponsors
Leads: Sichuan University

This content was sourced from clinicaltrials.gov

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