Non Small Cell Lung CancerPOSITHESNCT05103605
Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 46 sites in France.
Trial summary
This is an observational multicenter study. A cross-sectional descriptive study of patients with locally advanced or metastatic Non Small Cell Lung Cancer with activating EGFR mutation treated by any first line therapy will be used to identify cohort with a prospective follow-up of patients initiating a treatment by… 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
- 274 participants
- Where
- 46 sitesFrance
- Study dates
- 12 May 2021to 15 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study combining a descriptive cross-sectional survey (part B) and a prospective cohort design (part A). Patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) with activating EGFR mutation initiating a treatment by osimertinib in first line (Population A) Patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy (population B)
Who may be able to join
- Descriptive cross-sectional survey (Population B)
- Adult patients (≥ 18 years old),
- Patients newly treated in first line (1L) for locally advanced or metastatic NSCLC,
- Patients with activating EGFR mutation-positive,
- Patient informed and not opposed to these data collection.
- Prospective cohort (Population A)
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- Patient meeting part B inclusion criteria,
- Patients newly treated in 1L by osimertinib,
- Patient with common EGFR mutation-positive (exon 19 deletion or L858R mutation, alone or co-occuring with other EGFR mutations).
Who cannot join
- Patients enrolled in interventional clinical trials (first line treatment for a NSCLC) during the study period.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
France46 sites
Research Site
Abbeville
Research Site
Aix-en-Provence
Research Site
Angers
Research Site
Antibes
Research Site
Avignon
Research Site
Bastia
Research Site
Bayonne
Research Site
Bordeaux
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Cannes
Research Site
Chambéry
Research Site
Chauny
Research Site
Cholet
Research Site
Clermont-Ferrand
Research Site
Colmar
Research Site
Contamine-sur-Arve
Research Site
Créteil
Research Site
Elbeuf
Research Site
Epagny METZ Tessy
Research Site
Évreux
Research Site
La Roche-sur-Yon
Research Site
Libourne
Research Site
Limoges
Research Site
Lyon
Research Site
Marseille
Research Site
Meaux
Research Site
Mulhouse
Research Site
Orléans
Research Site
Paris
Research Site
Poitiers
Research Site
Quimper
Research Site
Reims
Research Site
Rouen
Research Site
Saint-Denis
Research Site
Saint-Grégoire
Research Site
Saint-Pierre
Research Site
Saint-Priest-en-Jarez
Research Site
Saint-Quentin
Research Site
Toulon
Research Site
Toulouse
Research Site
Valenciennes
Research Site
Vannes
Research Site
Villefranche-sur-Saône
Research Site
Villenave-dornon
Research Site
Villeurbanne
About this study
Official title: Positioning, Utilization and Effectiveness of Osimertinib in First Line in Real-life Therapeutic Strategy in France Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
This is an observational multicenter study. A cross-sectional descriptive study of patients with locally advanced or metastatic Non Small Cell Lung Cancer with activating EGFR mutation treated by any first line therapy will be used to identify cohort with a prospective follow-up of patients initiating a treatment by osimertinib in first line
- A cross-sectional descriptive study of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study which is transversal will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
- Additionally, a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address describe in real life conditions the 36-months overall survival, patients baseline characteristics, disease evolution, sequencing and treatment patterns, and quality of life
Read the detailed description
This is an observational multicenter study combining a descriptive cross-sectional survey and a prospective cohort design to address the study objectives.
Part A is a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address the primary objective of this study and remaining secondary objectives.
Part B is an additional descriptive cross-sectional survey of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study part which is cross sectional will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
Both studies will be initiated at the same time (depending on osimertinib reimbursement in France - expected on October 2020). Part A will have an enrolment period of approximately 18 months and a follow-up period of 36 months. Part B will have an enrolment period of 12 months.
For Part A, patients must be newly treated in first line and the index date will be the day of first line treatment initiation. Patients will be followed-up for all routine visits recorded until time to second progression. After the relapse of second line therapy, patients will be followed-up every 6 months for overall survival only until 36 months.
For Part B, patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period will be included.
Patients will be followed up from enrolment in part A until death, loss to follow-up, withdrawal of consent or study end date, whichever occurs first.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called TAGRISSO
Single arm treated by osimertinib
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
36-months overall survival defined as time from index date until death from any cause
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start12 May 2021
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard Auliac, Principal investigator, CHI Creteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103605
- Sponsor's protocol ID
- D5161R00017
- Acronym
- POSITHES
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2021
- Last updated
- 1 Dec 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning, Utilization and Effectiveness of Osimertinib in First Line in Real-life Therapeutic Strategy in France Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
- ClinicalTrials.gov ID
- NCT05103605
- Acronym / sponsor ID
- POSITHES / D5161R00017
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 274 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 2 Nov 2021 (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 an observational multicenter study. A cross-sectional descriptive study of patients with locally advanced or metastatic Non Small Cell Lung Cancer with activating EGFR mutation treated by any first line therapy will be used to identify cohort with a prospective follow-up of patients initiating a treatment by osimertinib in first line
- A cross-sectional descriptive study of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study which is transversal will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
- Additionally, a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address describe in real life conditions the 36-months overall survival, patients baseline characteristics, disease evolution, sequencing and treatment patterns, and quality of life
Detailed description
This is an observational multicenter study combining a descriptive cross-sectional survey and a prospective cohort design to address the study objectives.
Part A is a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address the primary objective of this study and remaining secondary objectives.
Part B is an additional descriptive cross-sectional survey of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study part which is cross sectional will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
Both studies will be initiated at the same time (depending on osimertinib reimbursement in France - expected on October 2020). Part A will have an enrolment period of approximately 18 months and a follow-up period of 36 months. Part B will have an enrolment period of 12 months.
For Part A, patients must be newly treated in first line and the index date will be the day of first line treatment initiation. Patients will be followed-up for all routine visits recorded until time to second progression. After the relapse of second line therapy, patients will be followed-up every 6 months for overall survival only until 36 months.
For Part B, patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period will be included.
Patients will be followed up from enrolment in part A until death, loss to follow-up, withdrawal of consent or study end date, whichever occurs first.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study combining a descriptive cross-sectional survey (part B) and a prospective cohort design (part A). Patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) with activating EGFR mutation initiating a treatment by osimertinib in first line (Population A) Patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy (population B)
Key inclusion criteria (9 listed)
- Descriptive cross-sectional survey (Population B)
- Prospective cohort (Population A)
Key exclusion criteria (1 listed)
- Patients enrolled in interventional clinical trials (first line treatment for a NSCLC) during the study period.
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: TAGRISSOSingle arm treated by osimertinib | Drug | – |
Primary outcome
Overall survival
Time frame: 36 months
36-months overall survival defined as time from index date until death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Jean-Bernard Auliac principal investigator
CHI Creteil, France
46 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 AstraZeneca at 46 sites in France.
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 9 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.