This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as neoadjuvant and adjuvant therapy for potential resectable stage III EGFR mutation-positive Non-small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Objective response rate (ORR)
ORR is defined as the proportion of patients who have completed the neoadjuvant treatment before operation and have achieved CR or PR as confirmed by CT evaluation in all patients.
Time frame: up to 4 months
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Time frame: up to 5 months
Event free survival (EFS)
It refers to the time from randomization to disease progression, cessation of treatment for any reason, or death
Time frame: up to 60 months
Overall survival (OS)
It is defined as the time from random enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Time frame: up to 60 months
R0 resection rate
complete removal of the tumor, with a negative microscopic margin indicating no residual tumor
Time frame: up to 6 months
Treatment-related adverse events
It refers to the number of adverse events related to HS-10296 as evaluated according to CTCAE v4.0.
Time frame: up to 13 months
Pathological complete response rate (pCR)
It refers to the number of cases with no residual invasive cancer in the primary tumor and lymph node HE staining accounted for the proportion of all patients who completed the treatment.
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Time frame: up to 24 months