Clinical trial NCT05103605: Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-11-02
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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)

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbeville Cedex
country: France
facility: Research Site
city: Aix En Provence Cedex 1
country: France
facility: Research Site
city: Angers Cedex 01
country: France
facility: Research Site
city: Antibes Cedex
country: France
facility: Research Site
city: Avignon Cedex 9
country: France
facility: Research Site
city: Bastia Cedex
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Bourg En Bresse
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Cannes Cedex
country: France
facility: Research Site
city: Chambery Cedex
country: France
facility: Research Site
city: Chauny Cedex
country: France
facility: Research Site
city: Cholet
country: France
facility: Research Site
city: Clermont-ferrand
country: France
facility: Research Site
city: Colmar Cedex
country: France
facility: Research Site
city: Contamine-sur-arve
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Elbeuf Cedex
country: France
facility: Research Site
city: Epagny METZ Tessy
country: France
facility: Research Site
city: Evreux
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Limoges Cedex
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille Cedex 08
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Meaux Cedex
country: France
facility: Research Site
city: Mulhouse
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Poitiers Cedex
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Rouen Cedex
country: France
facility: Research Site
city: Saint Denis
country: France
facility: Research Site
city: Saint Pierre
country: France
facility: Research Site
city: Saint Priest En Jarez Cedex
country: France
facility: Research Site
city: Saint-gregoire
country: France
facility: Research Site
city: Saint-quentin Cedex
country: France
facility: Research Site
city: Toulon Cedex 9
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Valenciennes
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Villefranche-sur-saone
country: France
facility: Research Site
city: Villenave-dornon
country: France
facility: Research Site
city: Villeurbanne
country: France
facility: Research Site
Study officials:
affiliation: CHI Creteil, France
name: Jean-Bernard Auliac
role: PRINCIPAL_INVESTIGATOR
References: