Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
POSITHES
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
1 other identifier
observational
274
1 country
46
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2021
CompletedFirst Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedDecember 1, 2025
November 1, 2025
4.7 years
October 21, 2021
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
36-months overall survival defined as time from index date until death from any cause
36 months
Interventions
Eligibility Criteria
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)
You may qualify if:
- 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)
- 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).
You may not qualify if:
- Patients enrolled in interventional clinical trials (first line treatment for a NSCLC) during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (46)
Research Site
Abbeville, France
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Aix-en-Provence, France
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Angers, France
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Antibes, France
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Avignon, France
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Bastia, France
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Bayonne, France
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Bordeaux, France
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Bourg-en-Bresse, France
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Brest, France
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Cannes, France
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Chambéry, France
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Chauny, France
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Cholet, France
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Clermont-Ferrand, France
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Colmar, France
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Contamine-sur-Arve, France
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Créteil, France
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Elbeuf, France
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Epagny METZ Tessy, France
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Évreux, France
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La Roche-sur-Yon, France
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Libourne, France
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Limoges, France
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Lyon, France
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Marseille, France
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Meaux, France
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Mulhouse, France
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Orléans, France
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Paris, France
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Poitiers, France
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Quimper, France
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Reims, France
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Rouen, France
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Saint-Denis, France
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Saint-Grégoire, France
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Saint-Pierre, France
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Saint-Priest-en-Jarez, France
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Saint-Quentin, France
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Toulon, France
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Toulouse, France
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Valenciennes, France
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Vannes, France
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Villefranche-sur-Saône, France
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Villenave-dornon, France
Research Site
Villeurbanne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Bernard Auliac
CHI Creteil, France
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2021
First Posted
November 2, 2021
Study Start
May 12, 2021
Primary Completion
January 15, 2026
Study Completion
January 15, 2026
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share