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

GFPC Investigation

Status and phase: Enrolling; Phase 4

Conditions: Lung Cancer; Non Small Cell Lung Cancer

Treatments: Procedure: G-Code; Genetic: Bio-bank repository; Other: Quality of Life (QoL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06646471

GFPC 05-2023

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Real world cohort of NSCLC older adults patients

Other group

Description:

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).

Treatment:

Other: Quality of Life (QoL)

Genetic: Bio-bank repository

Procedure: G-Code