EUCTR2016-002029-12-IE
Active, not recruiting
Phase 1
A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M - BOOSTER
DrugsAvastin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ETOP IBCSG Partners Foundation
- Enrollment
- 155
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Are the trial subjects under 18? no
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
Outcomes
Primary Outcomes
Not specified
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