Non-small Cell Lung Carcinoma
Conditions
Brief summary
This is a multicenter, randomized, open label, phase III study.
Detailed description
This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.
Interventions
DRUGAlmonertinib
Almonertinib 110mg PO once daily
DRUGPemetrexed
500 milligrams per square meter (mg/m²) Pemetrexed
DRUGCisplatin
75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
GeneCast Biotechnology Co., Ltd.
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
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 must be classified post-operatively as Stage II-IIIA on the basis of pathologic criteria. 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 randomization.
Exclusion criteria
* Any patient who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Defined as the proportion of patients alive and disease free at 2, 3 ,4and 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 100 months | Defined as the time from the date of randomization 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 randomization until treatment completion or discontinuation, assessed up to 100 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 randomization until 28 days after treatment completion | AEs graded by CTCAE version 4.0 |
Countries
China
Outcome results
None listed