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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 24, 2018
First Posted Date December 31, 2018
Last Update Posted Date April 8, 2020
Actual Study Start Date February 26, 2019
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients who have received Osimertinib in the SUMP in Spain.
Condition Non Small Cell Lung Cancer
Intervention Drug: Osimertinib
Patients treated with Osimertinib within the Special Use medication Program (SUMP).
Other Name: Tecentriq
Study Groups/Cohorts Not Provided
Publications * Provencio M, Terrasa J, Garrido P, Campelo RG, Aparisi F, Diz P, Aguiar D, García-Giron C, Hidalgo J, Aguado C, González JG, Esteban E, Gómez-Aldavarí L, Moran T, Juan O, Chara LE, Marti JL, Castro RL, Ortega AL, Moreno EM, Coves J, Sánchez Peña AM, Bosch-Barrera J, Gastaldo AS, Núñez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 25, 2019)
169
Original Estimated Enrollment
 (submitted: December 28, 2018)
270
Actual Study Completion Date April 1, 2020
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03790397
Other Study ID Numbers GECP 18/01_OSIREX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fundación GECP
Study Sponsor Fundación GECP
Collaborators Not Provided
Investigators
Principal Investigator: Mariano Provencio, MD Hospital Universitario Puerta de Hierro
PRS Account Fundación GECP
Verification Date April 2020