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Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive (OSIREX)

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ClinicalTrials.gov Identifier: NCT03790397
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación GECP

Study Description
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Brief Summary:
This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the treatment within the Special Use Medication Program (SUMP) in Spain.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Drug: Osimertinib

Detailed Description:

The study is based on the collection of data about the patients treated with Osimertinib within the Special Use medication Program. the patienes participating in this non-interventional study will not receive treatment in relation to the study.

Approximately a total of 270 patients will be included in this project from several Spanish sites. Around 52 hospitals will participate in the study. the observation period is from August 2016 to December 2018 and will include patients who started the treatment with Osimertininb from August 2016 to April 2018.

The primary objective is to estimate the progression free survival of the Osimertinib treatment.

Study Design
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Study Type : Observational
Actual Enrollment : 169 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program (SUMP) in Spain
Actual Study Start Date : February 26, 2019
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Groups and Cohorts
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Intervention Details:
  • Drug: Osimertinib
    Patients treated with Osimertinib within the Special Use medication Program (SUMP).
    Other Name: Tecentriq

Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    To estimate the progression free survival of the Osimertinib Treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who have received Osimertinib in the SUMP in Spain.
Criteria

Inclusion Criteria:

  • Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib treatment within the Spanish special use medication program of Osimertinib (SUMP).
  • Alive patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

  • Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
  • Patients who were accepted in the SUMP, but did not receive treatment.
Contacts and Locations
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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): NCT03790397


Locations
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Sponsors and Collaborators
Fundación GECP
Investigators
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Principal Investigator: Mariano Provencio, MD Hospital Universitario Puerta de Hierro
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundación GECP
ClinicalTrials.gov Identifier: NCT03790397    
Other Study ID Numbers: GECP 18/01_OSIREX
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Fundación GECP:
Lung Cancer, EGFR positive, NSCLC, Osimertinib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action