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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05103605
Collaborator
(none)
420
53
56.1
7.9
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational
Anticipated Enrollment :
420 participants
Observational Model:
Other
Time Perspective:
Other
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
Actual Study Start Date :
May 12, 2021
Anticipated Primary Completion Date :
Jan 15, 2026
Anticipated Study Completion Date :
Jan 15, 2026

Outcome Measures

Primary Outcome Measures

  1. Overall survival [36 months]

    36-months overall survival defined as time from index date until death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Abbeville Cedex France
2 Research Site Aix En Provence Cedex 1 France
3 Research Site Angers Cedex 01 France
4 Research Site Antibes Cedex France
5 Research Site Avignon Cedex 9 France
6 Research Site Bar Le Duc Cedex France
7 Research Site Bastia Cedex France
8 Research Site Bayonne France
9 Research Site Bordeaux Cedex France
10 Research Site Bourg En Bresse France
11 Research Site Brest France
12 Research Site Cannes Cedex France
13 Research Site Chambery Cedex France
14 Research Site Chauny Cedex France
15 Research Site Cholet France
16 Research Site Clermont-ferrand France
17 Research Site Colmar Cedex France
18 Research Site Contamine-sur-arve France
19 Research Site Creil Cedex France
20 Research Site Creteil France
21 Research Site Elbeuf Cedex France
22 Research Site Epagny METZ Tessy France
23 Research Site Evreux France
24 Research Site Jonzac France
25 Research Site La Roche Sur Yon France
26 Research Site Levallois Perret France
27 Research Site Libourne France
28 Research Site Limoges Cedex France
29 Research Site Lyon France
30 Research Site Marseille Cedex 08 France
31 Research Site Marseille France
32 Research Site Meaux Cedex France
33 Research Site Mulhouse France
34 Research Site Nancy France
35 Research Site Orleans France
36 Research Site Paris France
37 Research Site Poitiers Cedex France
38 Research Site Quimper France
39 Research Site Reims Cedex France
40 Research Site Rouen Cedex France
41 Research Site Saint Denis France
42 Research Site Saint Pierre France
43 Research Site Saint Priest En Jarez Cedex France
44 Research Site Saint Priest En Jarez Cedex France
45 Research Site Saint-gregoire France
46 Research Site Saint-quentin France
47 Research Site Toulon Cedex 9 France
48 Research Site Toulouse Cedex 9 France
49 Research Site Valenciennes France
50 Research Site Vannes France
51 Research Site Villefranche-sur-saone France
52 Research Site Villenave-dornon France
53 Research Site Villeurbanne France

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: Jean-Bernard Auliac, CHI Creteil, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT05103605
Other Study ID Numbers:
  • D5161R00017
First Posted:
Nov 2, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022