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Non-Small Cell Lung CancerOBSTINATENCT05049044

Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

An observational study of Non-Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 34 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers. Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis [TNM] stage III) patients represent approximately a third of newly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Quality of Life Questionnaire-Core 30 (QLQ-C30)
How many people
413 participants
Where
34 sitesFrance
Study dates
18 Dec 2020to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Every new patients diagnosed with treatment-naïve unresectable stage III non-small cell lung cancer (according to the 8th TNM IASLC edition). Unresectability could be due to either functional limitation or anatomical extension of the tumor.

Who may be able to join

  • Pathological confirmation of NSCLC obtained from a tumor cytology or biopsy
  • Treatment-naïve unresectable TNM stage III NSCLC (according to the 8th TNM IASLC edition). Of note, unresectability could be due to either functional limitation or anatomical extension of the tumor.
  • Patient willing and able to complete collection of data via self-assessment questionnaires
  • Patient without any local or systemic anti-neoplastic treatment are eligible (palliative symptomatic radiotherapy is considered best supportive care)
  • Patients participating in other interventional or non-interventional studies can be included.

Who cannot join

  • Early stage NSCLC initially treated locally (surgery or other) and classified as pathological TNM stage III (according to the 8th TNM IASLC edition)
  • At the treating physician's discretion, patient not eligible physically or psychologically to be included in a clinical trial
  • Inability to read and/or fill out self-assessment questionnaires
  • Patient unable to express opposition to data collection

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

France34 sites

  • Centre Hospitalier d'Aix en Provence

    Aix-en-Provence, 13616

  • CHU Amiens-Picardie

    Amiens, 80054

  • Centre Hospitalier Universitaire

    Angers, 49033

  • Centre Hospitalier d'Annecy

    Annecy, 74374

  • Centre Hospitalier du Morvan

    Brest, 29200

  • CHMS

    Chambéry, 73011

  • Hôpital Paul d'Egine

    Champigny-sur-Marne, 94500

  • Centre Hospitalier de Chauny

    Chauny, 02300

  • Centre Hospitalier du Cotentin

    Cherbourg, 50102

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • Centre Hospitalier d'Elbeuf - Pneumologie

    Elbeuf, 76503

  • CHD Les Oudairies

    La Roche-sur-Yon, 85000

  • Hôpital Robert Boulin

    Libourne, 33505

  • Centre Hospitalier Universitaire DUPUYTREN

    Limoges, 87042

  • Hôpital du Scorff

    Lorient, 56100

  • Centre Leon Bérard

    Lyon, 69373

  • Hôpital Européen

    Marseille, 130003

  • Hôpital Nord

    Marseille, 13915

  • Hôpital de Meaux

    Meaux, 77100

  • Centre Catalan d'Oncologie

    Perpignan, 66000

  • Centre Hospitalier Intercommunal de Quimper

    Quimper, 29000

  • CHU Ponchaillou

    Rennes, 35000

  • Hôpital Charles Nicolle

    Rouen, 76031

  • CHU La Réunion Site Nord

    Saint-Denis, 97411

  • Hôpital Privé de la Loire

    Saint-Etienne, 42000

  • CHU Hôpital Nord

    Saint-Etienne, 42055

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44600

  • CHU La Réunion Site Sud

    Saint-Pierre, 97410

  • Institut Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • CH de Bigorre Tarbes

    Tarbes, 65013

  • Hôpital d'Instruction des Armées Ste Anne

    Toulon, 83800

  • CH Bretagne Atlantique

    Vannes, 56017

  • Centre Hospitalier de Villefranche sur Saone

    Villefranche-sur-Saône, 69655

  • Centre hospitalier Intercommunal

    Villeneuve-Saint-Georges, 94190

Other trials in France

About this study

OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers.

Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis [TNM] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC.

The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.

Read the detailed description

OBSTINATE is an observational, prospective, national, multicentric study conducted in patients newly diagnosed with an unresectable stage III NSCLC (with exclusion of early stages NSCLC classified to pathological stage III).

OBSTINATE is a study planned to include 450 patients between 50 to 70 GFPC-affiliates or GFPC-associated centers approximately. All centers are located in France. The participating Site Investigators will be treating physicians within one of the participating centers.

After screening for eligibility checks, patients will receive the Patient Information Note from the Site Investigators. This Patient information Note will describe the study purpose and modalities. Patients who meet the eligibility criteria and do not oppose to data collection will be enrolled. The schedule of the medical visits in the study center will depend on the patient and his/her routine clinical care Protocol-relevant data will be collected by the treating physician within each center, for up to 5 years following the last patient's enrollment in the study.

Patients included in the study will complete the self-assess questionnaires at enrollment and during routine care follow-up, according to pre-specified data collection schedule.

Usual practices or modalities of follow-up of patients will remain unchanged compared to the current clinical practice as the study is designed to provide descriptive summary information.

Being tested
Quality of Life Questionnaire-Core 30 (QLQ-C30)
Keywords
Non-Small-cell lung cancer, Unresectable, Advanced stage
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of Life Questionnaire-Core 30 (QLQ-C30)Other

    Also called Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), 5-level EuroQoL EQ5D (EQ5D-5L)

    The HR-QoL evaluation is based on three self-assessment questionnaires distributed to the patients according to the pre-specified data collection schedule. Patients will also complete an additional questionnaire on socio-economic and occupational outcomes

Study groups in NCT05049044
Study groupRoleWhat they receive
Cohort 1: cRT-CT+IOConcomitant radio-chemotherapy and consolidation immunotherapy (cRT-CT+IO)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 2: sRT-CT+IOSequential radio-chemotherapy and consolidation immunotherapy (sRT-CT+IO)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 3: cRT-CTConcomitant radio-chemotherapy (cRT-CT)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 4: sRT-CTSequential radio-chemotherapy (sRT-CT)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 5: CTChemotherapy only (CT)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 6: CT+IOChemotherapy plus immunotherapy (CT+IO)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 7: RTRadiation therapy only (RT)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 8: IOImmunotherapy only (IO)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 9: TTTargeted therapy only (TT)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Cohort 10: BSCBest supportive care only (BSC)
Receives: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient)

    Change in patient's QLQ-C30 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.

    This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.

    The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.

    Measured: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned

  2. QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)

    Change in patient's QLQ-LC13 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.

    This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.

    The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.

    Measured: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned

  3. EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient)

    Change in patient's EQ5D-5L during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.

    This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.

    The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.

    Measured: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned

Secondary outcomes (18)

  1. Baseline demographics

    Stage III unresectable NSCLC patients characteristics: baseline patient demographics at stage III NSCLC diagnosis, clinical, pathological and molecular characteristics (e.g. age, race, comorbidities)

    Measured: At Baseline

  2. Tumor characteristics as defined by TNM stage

    Characterize the stage III unresectable NSCLC patients by TNM stage according to the 8th TNM IASLC edition

    Measured: At Baseline

  3. Tumor characteristics as defined by PD-L1 expression status

    Characterize the stage III unresectable NSCLC patients by PD-L1 expression status (tumor propensity score)

    Measured: At Baseline

  4. Tumor characteristics as defined by mutational status of driver genes

    Characterize the stage III unresectable NSCLC patients by mutational status of driver genes (e.g. epidermal growth factor receptor [EGFR]) anaplastic lymphoma kinase [ALK], reactive oxygen species 1 [ROS1], human epidermal growth factor receptor 2 [HER2], PI3KCA, BRAF, MET, rearranged during transfection [RET], neurotrophic receptor tyrosine kinase [NRTK])

    Measured: At Baseline

  5. Time from diagnosis to treatment

    Measured: From date of diagnosis until the date of first documented treatment or start date of best supportive care through study completion, up to 5 year

  6. Modality of follow-up

    Description of modality of follow-up (e.g. type of imagery used, frequency of medical visit)

    Measured: From date of diagnosis until the date of first documented progression or or date of death from any cause, whichever came first, assessed up to 5 years maximum

  7. Median PFS

    Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

    Measured: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

  8. Median time to progression

    Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

    Measured: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

  9. Median OS (e.g. median PFS, median OS)

    Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

    Measured: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

  10. Treatment characteristics

    Describe the chemotherapy, radiation therapy and immunotherapy protocols used (e.g. dose, reduction, interruptions, duration)

    Measured: From date of first treatment administration up to end of study, assessed up to 5 years maximum

  11. Best response of treatment

    Measured: From date of first treatment administration up to end of study, assessed up to 5 years maximum

  12. Duration of response of treatment

    Measured: From date of first treatment administration up to end of study, assessed up to 5 years maximum

  13. Toxicity of treatment

    limited to Cohorts 1, 2, 3 and 4 (restricted to significant AEs, which include but are not limited to: serious AEs [SAEs], AEs that led to treatment discontinuation, or any AEs ≥ grade 3 judged clinically significant by the Site Investigator)

    Measured: From date of first treatment administration up to end of study, assessed up to 5 years maximum

  14. Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision

    Concordance between effective treatment compared to initial MDTB decision

    Measured: From date of first treatment administration up to end of study, assessed up to 5 years maximum

  15. Type of progression (local, loco-regional, metastatic)

    Measured: At date of first documented progression, assessed up to 5 years maximum

  16. Description of second line of treatment after disease progression

    Treatment characteristics after disease progression including type of treatment (chemotherapy, radiotherapy, immunotherapy or Tyrosine-Kinase inhibitors), treatment duration, stop date of treatment and reason for end of treatment

    Measured: From date of first documented progression up to end of study, assessed up to 5 years maximum

  17. Change in patients' socio-economic and occupational outcomes using unique self questionnaire

    Change in patients' socio-economic and occupational outcomes during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study using a dedicated self questionnaire on socio-economic and occupational outcomes

    Measured: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum

  18. Evaluate the cost-utility of the therapeutic strategy using Quality-Adjusted Life Years (QALYs)

    Measured: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start18 Dec 2020
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049044
Sponsor's protocol ID
GFPC 06-2019
Acronym
OBSTINATE
Status last verified
Aug 2025
First submitted
13 Nov 2020
Last updated
4 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 34 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient) (time frame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2025.

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