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Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER) (BOOSTER)

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ClinicalTrials.gov Identifier: NCT03133546
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
AstraZeneca
Hoffmann-La Roche
Information provided by (Responsible Party):
European Thoracic Oncology Platform

Brief Summary:
BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small cell lung carcinoma (NSCLC) harbouring activating EGFR (exon 19 deletion or L858R) and T790M resistance mutation.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Metastatic Drug: Osimertinib Drug: Bevacizumab Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Osimertinib plus Bevacizumab
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Drug: Osimertinib

Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.

AstraZeneca will supply osimertinib as tablets for oral administration.

Other Name: Tagrisso

Drug: Bevacizumab
Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
Other Name: Avastin

Active Comparator: Osimertinib alone
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Drug: Osimertinib

Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.

AstraZeneca will supply osimertinib as tablets for oral administration.

Other Name: Tagrisso




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: PFS will be measured from date of patient enrolment until documented progression, or death, if progression is not documented, evaluated up to 48 months from enrolment of the first patient and compared between treatment arms. ]
    PFS in patients with locally advanced or metastatic NSCLC will be assessed according to RECIST 1.1 criteria.The two treatment arms will be compared using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: ORR will be evaluated from date of patient enrolment until termination of trial treatment across all assessment timepoints, evaluated up to 48 months from enrolment of the first patient and compared between treatment arms. ]
    ORR, defined as the percentage of patients reaching a complete or partial response, based on evaluation using RECIST 1.1 criteria and disease control rate.

  2. Disease Control [ Time Frame: Evaluated across all assessment timepoints from date of patient enrolment to termination of trial treatment, evaluated up to 48 months from enrolment of the first patient and compared between treatment arms. ]
    Disease control, defined as complete or partial response, or disease stabilisation confirmed at subsequent radiological assessment.

  3. Adverse Events [ Time Frame: From date of signature of informed consent until 30 days after all trial treatment discontinuation, for a maximum of 48 months from enrolment of the first patient ]
    Adverse events, graded by CTCAE 4.0, will be recorded from date of signature of informed consent until 30 days after all trial treatment discontinuation.

  4. Overall Survival (OS) [ Time Frame: Evaluated from date of enrolment until death from any cause, assessed at 48 months from enrolment of the first patient. ]
    Defined as the time from date of randomisation until death from any cause.


Other Outcome Measures:
  1. T790M evolution in tissue and plasma/serum between baseline and disease progression on trial treatment [ Time Frame: Assessed at baseline and disease progression on trial treatment (maximum 48 months) ]
    For this correlative studie tumour tissue blocks, plasma and serum samples will be collected at trial entry and at disease progression on trial treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (male/female) must be >18 years of age.
  • Patients diagnosed with NSCLC, stage IIIb/IIIc (not amenable to radical therapy) or IVa/IVb according to 8th TNM classification, after progression following prior EGFR TKI therapy (erlotinib, gefitinib, dacomitinib or afatinib) as the most recent treatment regimen;
  • Pathological diagnosis of predominantly non-squamous NSCLC;
  • Maximum one line of previous platinum based chemotherapy;
  • Histological or cytological confirmation of EGFRm (exon 19 deletion or exon 21L858R);
  • 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 treatment 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 according to RECIST 1.1;
  • Adequate haematological, renal and liver function;
  • World Health Organization (WHO) performance status 0-2.

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 progressive growth or increasing need of steroids.
  • Patients currently receiving medications or herbal supplements known to be potent CYP3A4 inducers;
  • Patients with any unresolved toxicities from prior therapy greater than CTCAE V 4.0 grade 1 (exception: alopecia & grade 2, prior platinuma-therapy related neuropathy)
  • Previous treatment with osimertinib and/or bevacizumab;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133546


Locations
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Ireland
St. James Hospital
Dublin, Ireland
Mid Western Cancer Centre
Limerick, Ireland
Korea, Republic of
National Cancer Centre
Goyang, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Netherlands
VU University Medical Centre
Amsterdam, Netherlands
Singapore
National University Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Spain
Hospital General Alicante
Alicante, Spain
Hospital Sant Pau
Barcelona, Spain
ICO Badalona
Barcelona, Spain
ICO Hospitalet
Barcelona, Spain
OSI Bilbao Basurto
Bilbao, Spain
Hospital Teresa Herrara
La Coruna, Spain
Fund. Jimenez Diaz
Madrid, Spain
Hospital de la Princesa
Madrid, Spain
Hospital la Paz
Madrid, Spain
Hospital Puerta de Hierro
Madrid, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Switzerland
Geneva University Hospital (HUG)
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
UniversitatSpital Zurich
Zurich, Switzerland
Sponsors and Collaborators
European Thoracic Oncology Platform
AstraZeneca
Hoffmann-La Roche
Investigators
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Study Chair: Solange Peters, MD Centre Hospitalier Universitaire Vaudois
Study Chair: Rolf Stahel, MD University Hospital Zuerich, Zurich, Switzerland

Publications:
Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

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Responsible Party: European Thoracic Oncology Platform
ClinicalTrials.gov Identifier: NCT03133546     History of Changes
Other Study ID Numbers: ETOP 10-16
2016-002029-12 ( EudraCT Number )
ESR-15-11666 ( Other Identifier: AstraZeneca )
MO39447 ( Other Identifier: Roche )
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Thoracic Oncology Platform:
NSCLC
EGFR
TKI
EGFRm
T790M

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Osimertinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action