Non Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Non small cell lung cancer (NSCLC)
Brief summary
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
Detailed description
This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC. Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy. Patients with metastatic EGFR T790M mutation-positive NSCLC, who are eligible to osimertinib treatment as per locally approved prescribing information and ratified by an independent clinical judgment of treating physician will be evaluated for the inclusion into the current phase-IV study based on eligibility criteria. EGFR T790M positivity on plasma or tissue biopsy on PCR-based platform will be considered appropriate test. EGFR T790M must be performed after progressive disease on last line of therapy (on or after EGFR TKI therapy). In order to enroll approximately 60 patients, it is expected that approximately 70 patients will be screened.
Interventions
DRUGOsimertinib
Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patient of either gender and ≥18 years of age 2. Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information 3. Each patient must sign an informed consent form (ICF)
Exclusion criteria
1. Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 2. Pregnant and/or lactating women 3. Patients participating in any current or future interventional trial will not be enrolled in the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Osimertinib | 5 months | Number of Patients with treatment emergent Adverse Events |
Countries
India
Participant flow
Recruitment details
This was a prospective, open label, single arm, multicentre, India-specific Phase 4 study to investigate the safety of osimertinib 80 mg tablet in Indian adults with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non small cell lung cancer (NSCLC). 60 Indian subjects were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm single arm, open label study and Osimertinib 80 mg tablet was given orally once daily. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 7 patients discontinued the study because of disease progression. | 7 |
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 58 Years |
| Race/Ethnicity, Customized Asian (Only Indian) | 60 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 60 |
| other Total, other adverse events | 51 / 60 |
| serious Total, serious adverse events | 7 / 60 |
Outcome results
Primary
Safety of Osimertinib
Number of Patients with treatment emergent Adverse Events
Time frame: 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety of Osimertinib | 60 Participants |