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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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 100mg QD
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGPathological 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 dose
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 dose
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 dose
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 administrated
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 administrated
Overall Survival (OS)
OS will be defined as the time from the date of first dosing until death due to any cause
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Time frame: From date of first administration up to approximately 5.5 years after the last patient is administrated
R0 resection rate
R0 resection rate is defined as the proportion of subjects with complete surgical resection with microscopically negative margins (no residual cancer cells at the edges of the excised tissue).
Time frame: Approximately 9-11 weeks after the first dose
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
Time frame: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery