A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BL-B01D1
DrugBL-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
DrugAlmonertinib 100mg QD
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: BL-B01D1 plus AlmonertinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Approximately 9-11 weeks after the first dose2
Major Pathological Response (MPR)
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
Time frame
Approximately 9-11 weeks after the first doseSecondary outcomes
1
Objective Response Rate（ORR）
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Time frame
Approximately 9-11 weeks after the first dose2
Event-free survival (EFS)
An event is defined as documented disease progression that precludes surgery or prevents completion of definitive surgery; recurrence or a new lesion, local or distant (a new primary malignancy, confirmed by pathology if clinically feasible, is not considered to be an EFS event); death due to any cause
Time frame
From date of first administration up to approximately 5.5 years after the last patient is administrated3
Disease free survival (DFS)
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Time frame
From date of first administration up to approximately 3.5 years after the last patient is administrated4
Overall Survival (OS)
OS will be defined as the time from the date of first dosing until death due to any cause
Time frame
From date of first administration up to approximately 5.5 years after the last patient is administratedOther outcomes
1
Biomarker expression in tumor tissues
Time frame
From date of first administration up to approximately 5.5 years after the last patient is administratedSponsors and contacts
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Source ClinicalTrials.gov