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

NCT ID: NCT03790397

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Osimertinib

Patients treated with Osimertinib within the Special Use medication Program (SUMP).

Intervention Type DRUG

Other Intervention Names

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Tecentriq

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación GECP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Provencio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro

Locations

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ICO Badalona

Badalona, Barcelona, Spain

Site Status

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Site Status

Hospital Universitario Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, Spain

Site Status

Hospital Universitario Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Site Status

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Lluís Alcanyís

Xàtiva, Valencia, Spain

Site Status

Hospital General de Albacete

Albacete, , Spain

Site Status

Hospital General Universitario Alicante

Alicante, , Spain

Site Status

Hospital de Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Complejo Asistencial Universitario de León

León, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Hospital General Universitario de Málaga

Málaga, , Spain

Site Status

Hospital Clínico de Salamanca

Salamanca, , Spain

Site Status

Hospital Virgen del Rocío

Seville, , Spain

Site Status

Hospital Virgen de la Salud

Toledo, , Spain

Site Status

Hospital Universitari i Politécnic La Fe

Valencia, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Hospital Clínico Lozano Blesa

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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Provencio M, Terrasa J, Garrido P, Campelo RG, Aparisi F, Diz P, Aguiar D, Garcia-Giron C, Hidalgo J, Aguado C, Gonzalez JG, Esteban E, Gomez-Aldavari L, Moran T, Juan O, Chara LE, Marti JL, Castro RL, Ortega AL, Moreno EM, Coves J, Sanchez Pena AM, Bosch-Barrera J, Gastaldo AS, Nunez NF, Del Barco E, Cobo M, Isla D, Majem M, Navarro F, Calvo V. Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group. BMC Cancer. 2021 Mar 6;21(1):230. doi: 10.1186/s12885-021-07922-5.

Reference Type DERIVED
PMID: 33676426 (View on PubMed)

Related Links

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http://www.gecp.org

Web page of the sponsor where users can find more information about Fundación GECP studies

Other Identifiers

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GECP 18/01_OSIREX

Identifier Type: -

Identifier Source: org_study_id

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