Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-002029-12-ES
EUCTR2016-002029-12-ES
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

ETOP (European Thoracic Oncology Platform)0 sites154 target enrollmentMarch 31, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPatients 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 therapyMedDRA version: 19.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsTagrissoAvastin

Overview

Phase
Phase 1
Intervention
Not specified
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
Sponsor
ETOP (European Thoracic Oncology Platform)
Enrollment
154
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 31, 2017
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ETOP (European Thoracic Oncology Platform)

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
  • •Cualquier toxicidad no resuelta de terapia previa mayor que CTCAE V 4\.0 grado 1

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
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)
EUCTR2016-002029-12-NLETOP (European Thoracic Oncology Platform)154
Completed
Phase 2
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
NL-OMON47703European Thoracic Oncology Platform ( ETOP)6
Active, not recruiting
Phase 1
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)
EUCTR2016-002029-12-IEETOP IBCSG Partners Foundation155
Active, not recruiting
Phase 2
A Phase 2 Study of Osimertinib in combination with Platinum-pemetrexed in patients with EGFR-mutated Advanced non-small cell Lung cancer.on-squamous non-small cell lung cancer
JPRN-jRCTs031180226Kobayashi Kunihiko66
Completed
Phase 2
Randomized phase II study of osimertinib plus ramucirumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutationsEGFR mutation-positive non-squamous non-small-cell lung cancerAdvanced non-squamous non-small cell lung cancer, EGFR mutation positive
JPRN-jRCT2080224085Kanagawa Cancer Center120