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

Study acronym: PROMETHEE
StatusRecruiting
PhasePhase 4
Started

Record status This record was last updated April 29, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Site details revised at 11 of 41 sitesv4
  2. Lead sponsor: Groupe Francais De Pneumo-Cancerologie to GFPC Investigationv3
  3. Study sites: 37 to 41v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06646471
Lead Sponsor GFPC Investigation
Conditions
(from sponsor)		 Non Small Cell Lung Cancer, Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov