Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations

Non Small Cell Lung Cancer Clinical Trial

— POSITHES  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05103605
• Other study ID #: D5161R00017
• Status: Active, not recruiting
• Start date: May 12, 2021
• Est. completion date: January 15, 2026

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

• 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).

Exclusion Criteria (Population A):

• Patients enrolled in interventional clinical trials (first line treatment for a NSCLC) during the study period.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Osimertinib
Single arm treated by osimertinib

Locations

Country	Name	City	State
France	Research Site	Abbeville Cedex
France	Research Site	Aix En Provence Cedex 1
France	Research Site	Angers Cedex 01
France	Research Site	Antibes Cedex
France	Research Site	Avignon Cedex 9
France	Research Site	Bastia Cedex
France	Research Site	Bayonne
France	Research Site	Bordeaux Cedex
France	Research Site	Bourg En Bresse
France	Research Site	Brest
France	Research Site	Cannes Cedex
France	Research Site	Chambery Cedex
France	Research Site	Chauny Cedex
France	Research Site	Cholet
France	Research Site	Clermont-ferrand
France	Research Site	Colmar Cedex
France	Research Site	Contamine-sur-arve
France	Research Site	Creteil
France	Research Site	Elbeuf Cedex
France	Research Site	Epagny METZ Tessy
France	Research Site	Evreux
France	Research Site	La Roche Sur Yon
France	Research Site	Libourne
France	Research Site	Limoges Cedex
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Marseille Cedex 08
France	Research Site	Meaux Cedex
France	Research Site	Mulhouse
France	Research Site	Orleans
France	Research Site	Paris
France	Research Site	Poitiers Cedex
France	Research Site	Quimper
France	Research Site	Reims Cedex
France	Research Site	Rouen Cedex
France	Research Site	Saint Denis
France	Research Site	Saint Pierre
France	Research Site	Saint Priest En Jarez Cedex
France	Research Site	Saint-gregoire
France	Research Site	Saint-quentin Cedex
France	Research Site	Toulon Cedex 9
France	Research Site	Toulouse Cedex 9
France	Research Site	Valenciennes
France	Research Site	Vannes
France	Research Site	Villefranche-sur-saone
France	Research Site	Villenave-dornon
France	Research Site	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	36-months overall survival defined as time from index date until death from any cause	36 months