NCT07243132

Brief Summary

The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment. Participants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study. They will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

46 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jul 2025Jan 2031

Study Start

First participant enrolled

July 2, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2031

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5.6 years

First QC Date

November 17, 2025

Last Update Submit

April 24, 2026

Conditions

Keywords

long-terms respondersMestastatic Lung CancerMetastatic NSCLCMetastatic small cell lung cancer

Outcome Measures

Primary Outcomes (7)

  • Baseline Clinical Characteristics

    Metastatic Lung Cancer Long-Terms Responders clinical characteristics: baseline patient demographics, clinical and pathological characteristics (e.g. age, medical history, comorbidities, past history of cancer, smoking status, NSCLC or SCLC characteristics)

    At Baseline visit, on a maximum period of 12 months.

  • Aix-Marseille-University (AMU) questionnaire

    At inclusion, 6 and 12 months after inclusion and every year up to 5 years

  • EORTC QLQ-LC13

    at inclusion, 6 and 12 months after inclusion and every year up to 5 years

  • Hospital Anxiety and Depression Scale (HAD)

    at inclusion, 6 and 12 months after inclusion and every year up to 5 years

  • Treatment characteristics

    Treatment characteristics are defined by the type of treatment, the numbers of cycle and the duration of treatment.

    From date of first lung cancer treatment administration up to 5 years

  • Health status

    Health status will be evaluated using Eastern Cooperative Oncology Group performance status (PS), and collecting data new diseases, cardiovascular, diabetes, second cancers

    At Baseline visit and up to 5 years

  • Socio-demographic characteristics

    Socio-demographic characteristics will be evaluated based on the following data: professional, socio-family and socio-economic characteristics, education, family status, potential professional exposure(s)

    At Baseline visit and up to 5 years

Secondary Outcomes (2)

  • Progression free survival (PFS)

    From date of first lung cancer treatment administration up to 5 years

  • Overall Survival (OS)

    From date of first lung cancer treatment initiation up to 5 years

Study Arms (1)

Long-Terms Responders in metastatic Lung Cancer

Long-term responders defined as patients alive for three years after diagnosis of metastatic Lung cancer (NSCLC and SCLC) and not receiving cytotoxic chemotherapy at the time of inclusion.

Behavioral: Hospital Anxiety and Depression scale (HAD)Behavioral: Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)Behavioral: Questionnaire Aix-Marseille-Université (AMU)

Interventions

The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), giving two scores (maximum score for each = 21).

Long-Terms Responders in metastatic Lung Cancer

The EORTC QLQ-LC13: a 13-item lung cancer-specific questionnaire module supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (cough, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

Long-Terms Responders in metastatic Lung Cancer

Data analysis will be firstly descriptive in order to report on the quality of life of respondents. Then, in a second stage, the factors associated with quality of life will be analyzed using linear or logistic regression models depending on the nature of the variable of interest.

Long-Terms Responders in metastatic Lung Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited by GFPC centers which is a large French network of hospitals and clinics particularly active in pneumology and thoracic oncology centers participating in clinical research. The principal investigator in each center will identify consecutive patients eligible for inclusion. Patients will be asked to confirm their consent for data collection.

You may qualify if:

  • Patient over 18 years old
  • Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance

You may not qualify if:

  • Difficulties for understanding French
  • Patients undergoing treatment with cytotoxic chemotherapy
  • Patients under legal guardianship, under curatorship or tutorship
  • Insufficient cognitive capacity to answer questions
  • Inability to obtain data collection (lost to follow-up, patient's refusal for data collection)
  • Patients refusing the collection of their data (an information sheet will be provided)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

CH du Pays d Aix

Aix-en-Provence, 13616, France

RECRUITING

CHU Angers

Angers, 49033, France

NOT YET RECRUITING

Hôpital Henri Duffaut

Avignon, 84000, France

RECRUITING

CH Bastia

Bastia, 20200, France

NOT YET RECRUITING

APHP Hôpital Avicennes

Bobigny, 93000, France

RECRUITING

CHU Morvan

Brest, 29200, France

RECRUITING

Hôpital Louis Pradel

Bron, 69500, France

NOT YET RECRUITING

Pneumologie Centre François Baclesse

Caen, 14000, France

NOT YET RECRUITING

Centre Hospitalier du Cotentin

Cherbourg, 50102, France

RECRUITING

CHU Hôpital Montpied

Clermont-Ferrand, 63000, France

RECRUITING

Oncologie CLCC Jean Perrin

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Pneumologie Hospices Civils de Colmar

Colmar, 68024, France

RECRUITING

Pneumologie Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

Centre Hospitalier d'Elbeuf - Pneumologie

Elbeuf, 76503, France

RECRUITING

CH Eure-Seine

Évreux, 27015, France

RECRUITING

Grand Hôpital de l'Est Francilien - Site Marne la Vallée

Jossigny, 77600, France

RECRUITING

Centre Hospitalier Les Oudairies

La Roche-sur-Yon, 85000, France

RECRUITING

CH La Rochelle

La Rochelle, 17000, France

RECRUITING

Hôpital Robert Boulin

Libourne, 33505, France

RECRUITING

Hôpital de la Vallée

Longjumeau, 91160, France

RECRUITING

Hôpital du Scorff

Lorient, 56100, France

RECRUITING

Pneumologie Hôpital privé Jean Mermoz

Lyon, 69085, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

NOT YET RECRUITING

Hôpital Européen

Marseille, 130003, France

NOT YET RECRUITING

Hôpital Nord - Oncologie Thoracique

Marseille, France

RECRUITING

GHEF Site de Meaux

Meaux, 77100, France

RECRUITING

CHRU de Nancy

Nancy, 54000, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44000, France

NOT YET RECRUITING

Pneumologie Hôpital Cochin

Paris, 75014, France

NOT YET RECRUITING

Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

Hôpital La Pitié-Salpêtrière

Paris, 75651, France

RECRUITING

Pneumologie Centre Hospitalier

Pau, 64000, France

RECRUITING

Centre Catalan d'Oncologie

Perpignan, 66000, France

RECRUITING

CHU Reims Hôpital Maison Blanche

Reims, 51000, France

NOT YET RECRUITING

CHU Hôpital Ponchailloux

Rennes, 35033, France

RECRUITING

Hôpital Charles Nicolle

Rouen, 76031, France

NOT YET RECRUITING

Hôpital Privé de la Loire

Saint-Etienne, 42000, France

RECRUITING

Pneumologie CHU St Etienne

Saint-Etienne, 42270, France

RECRUITING

CH des Vallées de l'Ariège

Saint-Jean-de-Verges, 09000, France

RECRUITING

CHU La Réunion Site Sud

Saint-Pierre, 97410, France

NOT YET RECRUITING

CHU La Réunion Site Sud

Saint-Pierre, 97410, France

RECRUITING

CH de Saint Malo

St-Malo, 35000, France

RECRUITING

Hôpital d'Instruction des Armées Saint-Anne

Toulon, 83041, France

RECRUITING

Hôpital Larrey

Toulouse, 31059, France

RECRUITING

Oncologie CH Bretagne-Atlantique

Vannes, 56000, France

RECRUITING

Centre Hospitalier de Villefranche sur Saone

Villefranche-sur-Saône, 69655, France

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Lionel FALCHERO

    GFPC

    PRINCIPAL INVESTIGATOR
  • Laurence BIGAY-GAME

    GFPC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

January 31, 2031

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations