Lung Adenocarcinoma
Conditions
Brief summary
This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Detailed description
Please refer to detailed description in the following context.
Interventions
DRUGFurmonertinib
Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
Sponsors
Allist Pharmaceuticals, Inc.
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study. * Primary lung adenocarcinoma diagnosed histologically/cytologically. * Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators. * EGFR mutation positive (19Del or L858R, with or without T790M) * The presence of at least one measurable lesion and suitable for accurate repeated measurements. * ECOG performance status 0-1. * For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
Exclusion criteria
* Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma. * Patients with EGFR exon 20 insertion mutation. * Exposure to other antitumor therapies prior to enrolment. * Major surgery was performed in the four weeks prior to the first dosing of the study drug. * Pregnant or lactating female patients. * Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration. * Have a history of or present complications with other malignancies. * Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study. * ECG QT interval prolongation or associated risk. * A history of interstitial pneumonia or related risk. * Inadequate bone marrow or organ reserve. * Other circumstances that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Approximately 8 weeks following the first dose of study drug | Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Approximately 8 weeks following the first dose of study drug | Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1 |
| Progression free survival (PFS) | Approximately 3 years following the first dose of study drug | The time from the first does of the study drugs to the progression of the disease or death for any reason. |
| Disease free survival (DFS) | Approximately 3 years following the first dose of study drug | The time from the end of surgery to the progression of the disease or death for any reason. |
| Adverse Events (AEs) | From the start of study drug to 28 days after the last dose of study drug | The number of patients with adverse events and the severity according to CTCAE v5.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor DNA clearance rate | Approximately 8 weeks following the first dose of study drug | The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy |
| Minimal residual disease rate | Approximately 12 weeks following the first dose of study drug | The proportion of patients with minimal residual disease defined as detectable ctDNA with a variant allele fraction of at least 0.1% in plasma after surgery |
Contacts
Primary ContactChangli Wang, MD
Outcome results
None listed