Non Small Cell Lung CancerOSIREXNCT03790397
Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
An observational study of Non Small Cell Lung Cancer, run by Fundación GECP at 31 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Osimertinib
- How many people
- 169 participants
- Where
- 31 sitesSpain
- Study dates
- 26 Feb 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have received Osimertinib in the SUMP in Spain.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital General de Albacete
Albacete, 02006
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital General Universitario Alicante
Alicante, 03010
ICO Badalona
Badalona, Barcelona, 08916
Hospital de Sant Pau
Barcelona, 08041
Hospital Universitario de Burgos
Burgos, 09006
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Dr. Josep Trueta
Girona, 17007
Hospital Universitario de Guadalajara
Guadalajara, 19002
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Complejo Asistencial Universitario de León
León, 24071
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Puerta de Hierro
Madrid, 28222
Hospital General Universitario de Málaga
Málaga, 29010
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, 07120
Hospital Universitario Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Hospital Clínico de Salamanca
Salamanca, 37007
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Hospital Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45071
Hospital Universitari i Politécnic La Fe
Valencia, 46009
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36036
Hospital Lluís Alcanyís
Xàtiva, Valencia, 46800
Hospital Clínico Lozano Blesa
Zaragoza, 50009
About this study
Official title: A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Osimertinib
- Keywords
- Lung Cancer, EGFR positive, NSCLC, Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called Tecentriq
Patients treated with Osimertinib within the Special Use medication Program (SUMP).
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
To estimate the progression free survival of the Osimertinib Treatment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start26 Feb 2019
- Primary completion15 Jul 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790397
- Sponsor's protocol ID
- GECP 18/01_OSIREX
- Acronym
- OSIREX
- Status last verified
- Jun 2022
- First submitted
- 24 Dec 2018
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33676426
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain
- ClinicalTrials.gov ID
- NCT03790397
- Acronym / sponsor ID
- OSIREX / GECP 18/01_OSIREX
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer, EGFR positive, NSCLC, Osimertinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have received Osimertinib in the SUMP in Spain.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: TecentriqPatients treated with Osimertinib within the Special Use medication Program (SUMP). | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Derived from this study: PubMed 33676426Provencio 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.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Provencio, MD principal investigator
Hospital Universitario Puerta de Hierro
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Fundación GECP at 31 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.