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

November 27, 2025 updated by: AstraZeneca

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France
        • Research Site
      • Aix-en-Provence, France
        • Research Site
      • Angers, France
        • Research Site
      • Antibes, France
        • Research Site
      • Avignon, France
        • Research Site
      • Bastia, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Bourg-en-Bresse, France
        • Research Site
      • Brest, France
        • Research Site
      • Cannes, France
        • Research Site
      • Chambéry, France
        • Research Site
      • Chauny, France
        • Research Site
      • Cholet, France
        • Research Site
      • Clermont-Ferrand, France
        • Research Site
      • Colmar, France
        • Research Site
      • Contamine-sur-Arve, France
        • Research Site
      • Créteil, France
        • Research Site
      • Elbeuf, France
        • Research Site
      • Epagny METZ Tessy, France
        • Research Site
      • La Roche-sur-Yon, France
        • Research Site
      • Libourne, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lyon, France
        • Research Site
      • Marseille, France
        • Research Site
      • Meaux, France
        • Research Site
      • Mulhouse, France
        • Research Site
      • Orléans, France
        • Research Site
      • Paris, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Quimper, France
        • Research Site
      • Reims, France
        • Research Site
      • Rouen, France
        • Research Site
      • Saint-Denis, France
        • Research Site
      • Saint-Grégoire, France
        • Research Site
      • Saint-Pierre, France
        • Research Site
      • Saint-Priest-en-Jarez, France
        • Research Site
      • Saint-Quentin, France
        • Research Site
      • Toulon, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Valenciennes, France
        • Research Site
      • Vannes, France
        • Research Site
      • Villefranche-sur-Saône, France
        • Research Site
      • Villenave-dornon, France
        • Research Site
      • Villeurbanne, France
        • Research Site
      • Évreux, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
36-months overall survival defined as time from index date until death from any cause
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5161R00017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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