A research study to compare the combined treatment of osimertinib and bevacizumab with osimertinib treatment alone in patients with lung cancer that has progressed or spread to other parts of the body (metastatic) and with confirmed specific gene mutations (changes) in the epithelial growth factor receptor (EGFR)

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002029-12-ES

Enrollment

154

Registered

2017-03-31

Start date

2017-04-04

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with locally advanced or metastatic (stage IIIb-IVb) EGFRm (exon 19 deletion or exon 21 L858R) NSCLC with T790M resistance mutation at progression on prior EGFR TKI therapy MedDRA version: 19.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Or

Interventions

Trade Name: Tagrisso Product Name: Osimertinib Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Osimertinib CAS Number: 1421373-65-0 Other descriptive name: OSIMERTINIB Concentration unit:

Eligibility

Sex/Gender

All

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154

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 • Cualquier toxicidad no resuelta de terapia previa mayor que CTCAE V 4.0 grado 1

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.;Secondary Objective: To compare short and long term clinical efficacy outcomes as well as tolerability of the two treatments.;Primary end point(s): Progression-free survival (PFS) based on RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: Time from the date of randomisation until documented progression or death, if progression is not documented	—

Measure

Time frame

Main Objective: To assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.;Secondary Objective: To compare short and long term clinical efficacy outcomes as well as tolerability of the two treatments.;Primary end point(s): Progression-free survival (PFS) based on RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: Time from the date of randomisation until documented progression or death, if progression is not documented

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Secondary

Measure	Time frame
Secondary end point(s): • Objective Response (OR), 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 (OS);Timepoint(s) of evaluation of this end point: • OR : across all assessment time-points during the period from randomisation to termination of trial Treatment • Disease control: across all assessment time-points during the period from randomisation to termination of trial Treatment • AEs:from date of signature of informed consent until 30 days after all Trial Treatment discontinuation • OS: time from the date of randomisation until death from any cause	—

Measure

Time frame

Secondary end point(s): • Objective Response (OR), 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 (OS);Timepoint(s) of evaluation of this end point: • OR : across all assessment time-points during the period from randomisation to termination of trial Treatment • Disease control: across all assessment time-points during the period from randomisation to termination of trial Treatment • AEs:from date of signature of informed consent until 30 days after all Trial Treatment discontinuation • OS: time from the date of randomisation until death from any cause

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Countries

Ireland, Korea, Republic of, Netherlands, Singapore, Spain, Switzerland

Contacts

Public ContactETOP Coordinating Office

ETOP

BOOSTER@etop-eu.org+4131511 94 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026