Lung Cancer
Conditions
Brief summary
Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
Detailed description
This is a multi-center, two-arm clinical study. In patients with stage I non-squamous non-small cell lung cancer (NSCLC) with EGFR 19del/21L858R with solid, micropapillary, and/or complex gland components ≥10% who have not received any systemic treatment, to evaluate the efficacy and safety of postoperative adjuvant Aumolertinib in NSCLC patients .
Interventions
DRUGAumolertinib
All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Baohui Han
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any patient who meets all of the following inclusion criteria will qualify for entry into the study: 1. Male or female, aged at least 18 years. 2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology. 3. Brain examination must be done prior to surgery as it is considered standard of care. 4. Patients are pathologically confirmed to be stage I after operation, containing solid, micropapillary, and/or complex gland components ≥10%. 5. Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. 6. Providing paraffin embedded section(10-15sheets),wax blocks or fresh frozen tissues. 7. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. 8. World Health Organization Performance Status of 0 to 1. 9. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test was negative. 10. Male patients should be willing to use barrier contraception from screening to stopping study treatment for 3 months.(i.e., condoms). 11. For inclusion in study, patient must provide a written informed consent. 12. ≤10 weeks between surgery and treatment period
Exclusion criteria
Any patient who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Disease free survival (DFS) rate | From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-, 4-, and 5-year DFS rate | From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Defined as the proportion of patients alive and disease free at 3, 4 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis. |
| Overall Survival (OS) | Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 60 months | Defined as the time from the date of treatment start until date of death due to any cause |
| Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey | From date of treatment start until treatment completion or discontinuation, assessed up to 60 months | Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | From date of treatment start until 28 days after treatment completion | AEs graded by CTCAE version 4.0 |
Countries
China
Contacts
Primary ContactBaohui Han, doctor
Outcome results
None listed