PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
Recruiting now · Phase 4
Conditions studied: Non Small Cell Lung Cancer, Lung Cancer
In brief
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
Key facts
- Study ID
- NCT06646471
- Run by
- GFPC Investigation
- People needed
- 500
- Starts
- 2024-09-26
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hôpital Nord OUest — Villefranche-sur-Saône, France (enrolling)
- Hôpital Henri Duffaut — Avignon, France (enrolling)
- Institut du Cancer d'Avignon — Avignon, France (enrolling)
- Pneumologie CHU St Etienne — Saint-Etienne, France (enrolling)
- Clinique Mutualiste — Saint-Nazaire, France (enrolling)
- CHU de la Réunion — Saint-Pierre, France (enrolling)
- CLCC Paul Strauss — Strasbourg, France (enrolling)
- Hôpital d'Instruction des Armées Saint-Anne — Toulon, France (enrolling)
- CHITS Toulon Sainte Musse — Toulon, France (enrolling)
- Oncologie CHBA — Vannes, France (enrolling)
- CH du Pays d Aix — Aix-en-Provence, France (enrolling)
- Oncologie Thoracique Hôpital Morvan — Brest, France (enrolling)
- CH Métropole-Savoie — Chambéry, France (enrolling)
- Centre Hospitalier du Cotentin — Cherbourg, France (enrolling)
- Pneumologie Hospices Civils de Colmar — Colmar, France (enrolling)
- Pneumologie CHI Creteil — Créteil, France (enrolling)
- CH Elbeuf — Elbeuf, France (enrolling)
- CHD Les Oudairies — La Roche-sur-Yon, France (enrolling)
- CH La Rochelle — La Rochelle, France (enrolling)
- Hôpital A. Mignot — Le Chesnay, France (enrolling)
- Hôpital Robert Boulin — Libourne, France (enrolling)
- CHU Dupuytren — Limoges, France (enrolling)
- Hôpital de la Vallée - Service Pneumologie — Longjumeau, France (enrolling)
- Centre Léon Bérard — Lyon, France (enrolling)
- Hôpital Européen de Marseille — Marseille, France (enrolling)
Full record on ClinicalTrials.gov
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