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

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

Recruiting
70 years and older
All
Phase 4

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Overview

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

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

Study details
    Non Small Cell Lung Cancer
    Lung Cancer

NCT06646471

Groupe Francais De Pneumo-Cancerologie

15 October 2025

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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