Lung cancer non-small cell lung cancer
Conditions
Interventions
All subjects will receive continuous daily treatment with osimertinib 80mg
once daily.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation., 2. WHO performance status 0-2., 3. Eligible for osimertinib treatment according to the label and according to the treating physician., 4. Patients must be >=18 years of age.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic central nervous system metastases who are neurologically unstable. Unstable brain metastases except for those who have completed definitive therapy and have had a stable neurological status for 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks prior to the start of study treatment and are clinically asymptomatic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with a resistant clone detected before radiological progression will be calculated as a percentage of total number of patients. The success rate of crizotinib treatment to eliminate resistance due to MET amplification will be calculated as the percentage of patients with disappearance of MET amplification in a subsequent ctDNA sample (not necessarily the first ctDNA following MET directed treatment) of the total number of patients with MET amplification detected in the ctDNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Lag time between ctDNA based detection of a resistant clone and radiological progression will be calculated as a median with 95% confidence interval. This parameter will be calculated for all resistance mechanisms combined, as well as for the individual resistance mechanisms. The time to re-appearance of the MET amplification clone after successful elimination after crizotinib treatment will be calculated as a median with 95% confidence interval. | — |
Countries
Netherlands
Outcome results
None listed