Non-small cell lung cancer
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Patients must be >= 18 years of age. 3. Locally advanced or metastatic non-small cell lung cancer, not amenable to curative surgery or radiotherapy 4. Presence of an EGFR exon 20, non-T790M, mutation, deletions and/or insertion only, 5. ECOG performance score of 0-2 6. Patients must have a life expectancy >= 12 weeks. 7. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria two weeks before screening. Male patients should be willing to use barrier contraception. 8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 9. At least one lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements. 10. Brain metastasis, if asymptomatic, are allowed. In case of symptomatic brain metastasis, patient must have had radiotherapy and stable for at least 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Presence of a T790M mutation or other tumour driven mutations, translocations or amplifications (e.g. common EGFR mutations, KRAS, BRAF V600E, ALK, ROS1) 2. Patient is unwilling and unable to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up 3. Previous treatment with EGFR-TKI 4. Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior). 5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy or immune mediated pneumonitis or hepatitis previously treated with IO therapy. 6. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses. 7. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable 8. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD 9. Inadequate bone marrow reserve or organ function. 10. Any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) > 470 msec obtained from 1 electrocardiograms, using the screening clinic ECG machine derived QTc value - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval 11. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib 12. Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry 13. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements 14. History of hypersensitivity active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best response defined by RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression free survival (PFS) is defined by RECIST 1.1 - Duration of response - Overall survival - Treatment- related adverse events (CTC-AE, v4.0) | — |
Countries
Netherlands
Outcome results
None listed