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PROspective Master-protocol f...

PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-26

Study Completion Date

2028-08-31

Brief Summary

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The objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (Non-Small-Cell Lung Carcinoma) according to best standard of care as defined by the European Society for Medical Oncology (ESMO). This cohort will aim to:

* characterize participants in terms of geriatrics, biology and carcinology
* describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life.

At the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy.

Participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. They will be asked to:

* visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment.
* perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy).
* provide blood samples for bio-bank repository
* perform assessments specific to older adults
* answer three quality of life questionnaires

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Real world cohort of NSCLC older adults patients

Cohort of patients ≥70 years of age with NSCLC treated in first line therapy for thoracic tumors according to ESMO-referenced therapeutic standards or according to an innovative molecule and/or strategy.

An optional biobank based on blood samples taken during the screening phase prior to the first administration of systemic treatment will be collected. Sampling of tumoral materials will be collected prior to study participation and send for central reading.

Patients will be asked to come at the hospital for their regular visits as per site current practice and to complete three quality of life questionnaires (EORTC QLQ-F17; QLQ-LC13; QLQ-ELD14).

Group Type OTHER

Bio-bank repository

Intervention Type GENETIC

Blood samples taken during the screening phase prior to the first administration of systemic treatment and stored in a repository for a maximum duration of 10 years

Quality of Life (QoL)

Intervention Type OTHER

Collection of EORTC QoL questionnaires QLQ-F17, QLQ-LC13 and QLQ-ELD14:

* stage 3 non-operable/non-radiable, stage 4: at inclusion, 12 weeks, 6 months of treatment, first-line progression.
* operable stage 1 to 3b: at inclusion, end of neoadjuvant period before surgery post-operative baseline, at 6 months, at 12 months.
* radiable stages 3a to 3c: at inclusion, at the end of thoracic radiotherapy, at 6 months, at 12 months.

G-Code

Intervention Type PROCEDURE

G-CODE: Katz Autonomy Scale (ADL), Instrumental Activities of Daily Living questionnaire (IADL), Charlson score, mini GDS, mini COG, falls history, Timed Get Up and Go test, social environment.

Interventions

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Bio-bank repository

Blood samples taken during the screening phase prior to the first administration of systemic treatment and stored in a repository for a maximum duration of 10 years

Intervention Type GENETIC

Quality of Life (QoL)

Intervention Type OTHER

G-Code

G-CODE: Katz Autonomy Scale (ADL), Instrumental Activities of Daily Living questionnaire (IADL), Charlson score, mini GDS, mini COG, falls history, Timed Get Up and Go test, social environment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient ≥70 years
* Non-small-cell lung cancer for which the multidisciplinary consultation required systemic treatment regardless of Tumor-Node-Metastasis (TNM) stage
* Patient naïve to systemic anticancer treatment for bronchial neoplasia
* Patient covered by social security
* Patient eligible for systemic treatment
* Systemic treatment with marketing authorization in the indication, available in routine care early access or compassionate access.
* Patient able to understand the protocol
* Patient not opposed to the collection of data concerning him/her
* Signature of study consent form.

Exclusion Criteria

* Patients under guardians or curators
* Patient not under the care of the investigating center and not monitored by the investigating center
* Patient already treated with systemic therapy for NSCLC

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent GREILLIER, Professor

Role: STUDY_CHAIR

Groupe Français de Pneumo-Cancérologie (GFPC)

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France

Central Contacts

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Romain CORRE, Medical Doctor

Role: CONTACT

[email protected]

+330298526404

Soizic FERLANDIN

Role: CONTACT

[email protected]

+330663224789

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GFPC 05-2023

Identifier Type: -

Identifier Source: org_study_id

PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Real world cohort of NSCLC older adults patients

Bio-bank repository

Quality of Life (QoL)

G-Code

Interventions

Bio-bank repository

Quality of Life (QoL)

G-Code

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GFPC Investigation

Responsible Party

Principal Investigators

Laurent GREILLIER, Professor

Locations

CH du Pays d Aix

Hôpital Henri Duffaut

Institut du Cancer d'Avignon

CH Bastia

Oncologie Thoracique Hôpital Morvan

Pneumologie Centre François Baclesse

CH Métropole-Savoie

Centre Hospitalier du Cotentin

CHU Hôpital Montpied

Pneumologie Hospices Civils de Colmar

Pneumologie CHI Creteil

CH Elbeuf

Polyclinique de Blois

CHD Les Oudairies

CH La Rochelle

Hôpital A. Mignot

Hôpital Robert Boulin

CHU Dupuytren

Hôpital de la Vallée - Service Pneumologie

Centre Léon Bérard

Hôpital Européen de Marseille

Oncologie Thoracique Hôpital Nord

GHEF Site de Meaux

Centre d Oncologie de Gentilly

Pneumologie CHR

Pneumologie Hôpital Cochin

Pneumologie Hôpital Tenon

Cantre Catalan d Oncologie

CH Annecy Genevois

Pneumologie CHI Quimper

CHU Hôpital Ponchailloux

Pneumologie Hôpital Charles Nicolle

Pneumologie CHU Felix Guyon

Pneumologie CHU St Etienne

Clinique Mutualiste

CHU de la Réunion

CLCC Paul Strauss

Hôpital d&#39;Instruction des Armées Saint-Anne

CHITS Toulon Sainte Musse

Oncologie CHBA

Hôpital Nord OUest

Countries

Central Contacts

Romain CORRE, Medical Doctor

Soizic FERLANDIN

Facility Contacts

Stéphanie MARTINEZ

Nicolas CLOAREC

Magali RAVOIRE

Pascal THOMAS

Renaud DESCOURT

Hubert CURCIO

Julian PINSOLLE

Laure KALUZINSKI

Patrick MERLE

Hôpital d'Instruction des Armées Saint-Anne