EGFR T790M mutation-positive non-small cell lung cancer
Conditions
Interventions
During enrolment patient will be randomized in one of the following arms
Experimental arm: Osimertinib, 80 mg p.o., once daily plus bevacizumab 15 mg/kg
i.v. on day 1 of every 3-week cycle. The initial infusion of bevacizumab should
be given over 90 minutes. If the initi
bevacizumab
non-small cell lung cancer
osimertinib
Stage IIIb-IVb
Sponsors
European Thoracic Oncology Platform ( ETOP)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • NSCLC, stage IIIb/IIIc (not amenable to radical therapy) or IVa/IVb according to 8th TNM classification, after progression following prior EGFR TKI (erlotinib, gefitinib, dacomitinib or afatinib) therapy as the most recent treatment regimen • Pathological diagnosis of predominantly non-squamous NSCLC. • Maximum of one line of previous platinum based chemotherapy. • Histological or cytological confirmation of EGFRm (exon19 deletion or exon 21 L858R). • Locally confirmed T790M mutation determined from biopsy (preferred) or on circulating tumour DNA, documented in tissue, plasma or serum after disease progression on the most recent EGFR TKI regimen. • Plasma, serum, and tumour (preferred) tissue or cytology (if biopsy was taken and FFPE tumor material is not yet fully depleted) after disease progression on the most recent EGFR TKI treatment available for central confirmation of T790M. • Measurable or evaluable disease • Adequate haematological, renal and liver function • Performance status 0-2
Exclusion criteria
Exclusion criteria: • Patients with mixed NSCLC with predominantly squamous cell cancer, or with any small cell lung cancer (SCLC) component. • Symptomatic or active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. • Previous treatment with osimertinib and/or bevacizumab • Patients currently receiving medications or herbal supplements known to be potent CYP3A4 inducers • Any unresolved toxicities from prior therapy greater than CTCAE V 4.0 grade 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) based on RECIST 1.1 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| • Objective response, based on RECIST 1.1 criteria • Disease control, defined as complete or partial response, or disease stabilisation, confirmed at subsequent radiological assessment • Adverse events graded by CTCAE V4.0 • Overall survival | — |
Countries
The Netherlands
Outcome results
None listed