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

April 24, 2026 updated by: GFPC Investigation

PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Real world cohort of NSCLC older adults patients

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).
Genetic: Bio-bank repository
Blood samples taken during the screening phase prior to the first administration of systemic treatment and stored in a repository for a maximum duration of 10 years
Other: Quality of Life (QoL)

Collection of EORTC QoL questionnaires QLQ-F17, QLQ-LC13 and QLQ-ELD14:

  • stage 3 non-operable/non-radiable, stage 4: at inclusion, 12 weeks, 6 months of treatment, first-line progression.
  • operable stage 1 to 3b: at inclusion, end of neoadjuvant period before surgery post-operative baseline, at 6 months, at 12 months.
  • radiable stages 3a to 3c: at inclusion, at the end of thoracic radiotherapy, at 6 months, at 12 months.
Procedure: G-Code
G-CODE: Katz Autonomy Scale (ADL), Instrumental Activities of Daily Living questionnaire (IADL), Charlson score, mini GDS, mini COG, falls history, Timed Get Up and Go test, social environment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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

The Progression Free Survival is defined as the time between treatment start date and event date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first.

Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let to the investigator 's discretion and local practices.

The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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
The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices.
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
Overall Survival (OS)
Time Frame: From the treatment start date up to the date of death for a 2-year-period maximum
Overall survival (OS) is calculated as the time between the date of treatment initiation and date of death, and censored at date of last news for patients alive at the end of the study.
From the treatment start date up to the date of death for a 2-year-period maximum
Duration of Response (DOR)
Time Frame: From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum
The duration of response is defined as the time between the date of the first response assessed by RECIST 1.1 to the date of progression or death for any cause, whichever comes first, and censored at the date of last tumor evaluation for patients still responding to treatment at the end of the study (after 2 years).
From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum
Time to Response (TTR)
Time Frame: From the start date of treatment up to the date of first response or for a 2-year-period maximum
Time to response is measured from the date of treatment initiation to the date of first response as defined by RECIST 1.1.
From the start date of treatment up to the date of first response or for a 2-year-period maximum
Treatment Duration
Time Frame: From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.
The duration of treatment is defined as the time between the treatment start date and the date of definitive cessation of treatment, whatever the cause.
From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.
Safety events
Time Frame: From the enrollment up to the participants study end date or for a 2-year-period maximum
All adverse events experienced by the participants, whatever the grades of toxicity, will be collected according to CTCAE v4.0 (common terminology criteria for adverse events).
From the enrollment up to the participants study end date or for a 2-year-period maximum
Treatments description
Time Frame: From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum
The treatments for NSCLC will be described including the adaptations: discontinuations, treatment interruptions, dose adaptations. The reasons for the changes will be recorded.
From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum
Geriatric interventions: specialized consultations
Time Frame: From the enrollment up to the participant study end date or for a 2-year-period maximum
The specialized geriatric consultations carried out to correct frailties will be collected during the study participation including psychological and/or dietetic consultations.
From the enrollment up to the participant study end date or for a 2-year-period maximum
Geriatric interventions: specialized exercises
Time Frame: From the enrollment up to the participant study end date or for a 2-year-period maximum
The specialized geriatric exercises carried out to correct frailties will be collected during the study participation including prescription of adapted physical activity and/or cognitive stimulation exercises.
From the enrollment up to the participant study end date or for a 2-year-period maximum
Geriatric interventions: specialized help at home
Time Frame: From the enrollment up to the participant study end date or for a 2-year-period maximum
The specialized geriatric interventions at home carried out to correct frailties will be collected during the study participation including home visits by a nurse or home help.
From the enrollment up to the participant study end date or for a 2-year-period maximum
Geriatric interventions: specialized medications
Time Frame: From the enrollment up to the participant study end date or for a 2-year-period maximum
The specialized geriatric medications carried out to correct frailties will be collected during the study participation.
From the enrollment up to the participant study end date or for a 2-year-period maximum
European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17)
Time Frame: At enrolment, at 12 weeks, at 6 months and at 12 months.

The QLQ-F17 is a validated cancer-specific questionnaire specific to cancer. It includes 17 items to assess 6 QoL scales: 1 global health scale and 5 functional scales (physical, role,emotional, cognitive, social). This is a shortened version of the QLQ-C30, containing only the functional and overall quality of life sections. This questionnaire was developed by the EORTC in order to optimize the collection of quality-of-life data, and to avoid overloading the patient with a lengthy questionnaire.

Symptoms will be assessed via modules. A score is generated for each dimension and standardized on a scale from 0 to 100, so that a high score reflects a high overall health status, a high functional level and a high symptomatic level. According to EORTC recommendations, the score can be calculated if at least 50% of the items in the corresponding dimension have been completed. Otherwise, the score will be considered missing.
At enrolment, at 12 weeks, at 6 months and at 12 months.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14)
Time Frame: At enrolment, at 12 weeks, at 6 months and at 12 months

The QLQ-ELD14 questionnaire is specific to elderly cancer patients. It contains 14 items measuring 7 dimensions of quality of life : two functional dimensions (maintaining a positive positive vision/motivation, family support) and 5 symptomatic dimensions (mobility, worries about others, worries about the future, disease burden, joint problems).

All of the scales and single-item range in score from 0-100. A score is generated for each dimension, so that a high score reflects a high functional level (for the scales concerned), and a high symptomatic level (for the scales concerned).
At enrolment, at 12 weeks, at 6 months and at 12 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
Time Frame: At enrolment, at 12 weeks, at 6 months and at 12 months

The QLQ-LC13 is a lung cancer-specific questionnaire containing 13 items to assess symptoms specific to lung cancer and its treatment: dyspnea, cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm or shoulder pain or shoulder pain, pain in other parts, anti-inflammatory drugs, drugs for pain. A score is generated per dimension so that a high score reflects a high symptomatic level.

All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level.

Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for symptom scale/item represents a high level of symptomatology/problems.
At enrolment, at 12 weeks, at 6 months and at 12 months
Geriatric characteristics G8 score
Time Frame: At enrollment and at disease progression for a maximum of 2-year-period.

The following geriatric characteristics will be collected is available in the participant medical file: G8 score.

The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
At enrollment and at disease progression for a maximum of 2-year-period.
Geriatric characteristics Geriatric Core DatasEt (G-CODE)
Time Frame: At enrollment and at disease progression for a maximum of 2-year-period.

The following geriatric characteristics will be collected is available in the participant medical file: Geriatric Core DatasEt (G-CODE). G-CODE is a core set of geriatric data. It has ten tools/items and a median completion time of 9 min. It includes Katz autonomy scale (ADL), Instrumental Activities of Daily Living (IADL), Charlson score, mini Geriatric Depression Sale (mini-GDS), short cognitive impairment screening exam (mini COG), falls history, Timed Get Up and Go test, social environment.

The G-CODE allows for a minimal geriatric description of the older cancer population and standardisation of geriatric data, enabling comparison across trials.
At enrollment and at disease progression for a maximum of 2-year-period.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biobank sampling
Time Frame: At inclusion
Blood samples will be collected at inclusion, before the first administration of NSCLC therapy, for exploratory analyses in ancillary studies
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GFPC Investigation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Laurent GREILLIER, Professor, Groupe Français de Pneumo-Cancérologie (GFPC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GFPC 05-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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