Clinical trial NCT06646471: PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
Official title: PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Non Small Cell Lung Cancer
Lung Cancer
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years
measure: Overall Survival (OS)
timeFrame: From the treatment start date up to the date of death for a 2-year-period maximum
measure: Duration of Response (DOR)
timeFrame: From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum
measure: Time to Response (TTR)
timeFrame: From the start date of treatment up to the date of first response or for a 2-year-period maximum
measure: Treatment Duration
timeFrame: From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.
measure: Safety events
timeFrame: From the enrollment up to the participants study end date or for a 2-year-period maximum
measure: Treatments description
timeFrame: From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum
measure: Geriatric interventions: specialized consultations
timeFrame: From the enrollment up to the participant study end date or for a 2-year-period maximum
measure: Geriatric interventions: specialized exercises
timeFrame: From the enrollment up to the participant study end date or for a 2-year-period maximum
measure: Geriatric interventions: specialized help at home
timeFrame: From the enrollment up to the participant study end date or for a 2-year-period maximum
measure: Geriatric interventions: specialized medications
timeFrame: From the enrollment up to the participant study end date or for a 2-year-period maximum
measure: European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17)
timeFrame: At enrolment, at 12 weeks, at 6 months and at 12 months.
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14)
timeFrame: At enrolment, at 12 weeks, at 6 months and at 12 months
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
timeFrame: At enrolment, at 12 weeks, at 6 months and at 12 months
measure: Geriatric characteristics G8 score
timeFrame: At enrollment and at disease progression for a maximum of 2-year-period.
measure: Geriatric characteristics Geriatric Core DatasEt (G-CODE)
timeFrame: At enrollment and at disease progression for a maximum of 2-year-period.
Other outcomes:
measure: Biobank sampling
timeFrame: At inclusion
Locations:
city: Aix En Provence
country: France
facility: CH du Pays d Aix
city: Avignon
country: France
facility: Hôpital Henri Duffaut
city: Bastia
country: France
facility: CH Bastia
city: Brest
country: France
facility: Oncologie Thoracique Hôpital Morvan
city: Caen
country: France
facility: Pneumologie Centre François Baclesse
city: Chambery
country: France
facility: CH Métropole-Savoie
city: Clermont-ferrand
country: France
facility: CHU Hôpital Montpied
city: Colmar
country: France
facility: Pneumologie Hospices Civils de Colmar
city: Creteil
country: France
facility: Pneumologie CHI Creteil
city: Elbeuf
country: France
facility: CH Elbeuf
city: La Chaussee Saint Victor
country: France
facility: Polyclinique de Blois
city: La Roche Sur Yon
country: France
facility: CHD Les Oudairies
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Chesnay
country: France
facility: Hôpital A. Mignot
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Oncologie Thoracique Hôpital Nord
city: Meaux
country: France
facility: GHEF Site de Meaux
city: Nancy
country: France
facility: Centre d Oncologie de Gentilly
city: Orleans
country: France
facility: Pneumologie CHR
city: Paris
country: France
facility: Pneumologie Hôpital Cochin
city: Paris
country: France
facility: Pneumologie Hôpital Tenon
city: Perpignan
country: France
facility: Cantre Catalan d Oncologie
city: Pringy
country: France
facility: CH Annecy Genevois
city: Quimper
country: France
facility: Pneumologie CHI Quimper
city: Rennes
country: France
facility: CHU Hôpital Ponchailloux
city: Rouen
country: France
facility: Pneumologie Hôpital Charles Nicolle
city: Saint Denis
country: France
facility: Pneumologie CHU Felix Guyon
city: Saint Nazaire
country: France
facility: Clinique Mutualiste
city: Saint-etienne
country: France
facility: Pneumologie CHU St Etienne
city: Saint-pierre
country: France
facility: CHU de la Réunion
city: Strasbourg
country: France
facility: CLCC Paul Strauss
city: Toulon
country: France
facility: Hôpital d&#39;Instruction des Armées Saint-Anne
city: Toulon
country: France
facility: CHITS Toulon Sainte Musse
city: Vannes
country: France
facility: Oncologie CHBA
city: Villefranche Sur Saone
country: France
facility: Hôpital Nord OUest
Study officials:
affiliation: Groupe Français de Pneumo-Cancérologie (GFPC)
name: Laurent GREILLIER, Professor
role: STUDY_CHAIR
References: