Non-small Cell Lung Cancer
Conditions
Keywords
furmonertinib, AST2818
Brief summary
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
Interventions
DRUGFurmonertinib+cisplating/pemetrexed
Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With written informed consent before any study procedure * Histology or cytology diagnose of non-small cell lung cancer within 60 days * Stage IIA-IIIB (T3N2M0 only), with resectable lesion(s) by radiology * EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations) * Without prior anti-tumor treatment * With at least one measurable lesions * ECOG performance status 0-1 * Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
Exclusion criteria
* EGFR Exon 20 insertions positive * Mixed with small cell cancer, or other mixed types of lung cancer * Any prior anti-tumor treatment * Major surgery within 4 weeks before enrollment * Women with pregnancy or breastfeeding * Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment * With history of other malignancy except for radical resected tumors without recurrence for 5 years or more * With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment * Severe gastrointestinal diseases which may affect the intake and absorption of study drug * Prolongation of ECG QTc or with relative risk factors * History of interstitial lung disease or with relative risk factors * Inadequate organ function of hematology, liver and kidney * Allergic to study drugs or any component * Poor adherence or other situation judged by investigator * Patients who had participated other clinical studies of tumors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 7 days before surgery | the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response rate | 7 days after surgery | MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR |
| Pathological complete response rate | 7 days after surgery | pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response |
| R0 resection rate | 7 days after surgery | the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery |
| the TNM downstaging rate | 7 days before surgery | defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage |
| Event-free survival | 2 years | defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause |
| Overall survival | Approximately 5 years following the first dose of study drugs | The time from enrolment to death of any reason |
| drug safety and surgical complications | Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days. | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo |
Countries
China
Outcome results
None listed