An observational study in Non-Small Cell Lung Cancer, sponsored by Groupe Francais De Pneumo-Cancerologie. Active, not recruiting at 34 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-04.
Sponsored by Groupe Francais De Pneumo-Cancerologie · Observational
Among 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France — 170 open to participants now, 328 under way, 106 of them phase 3. Carcinoma, Non-Small-Cell Lung · France.
Among the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, this one is the 21st largest by enrollment of the 104 observational ones, is one of 51 that started in 2020, is one of 104 observational ones, reaches primary completion later than 150 of the 325 other live ones, and was the 549th registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 413 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →170 of the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →872 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 51 started in 2020.
Median enrollment 190 across the 759 interventional studies, 151 across the 104 observational. Of the 512 that completed or were terminated, 257 (50%) have results posted.
611 of 872 have an industry lead sponsor. The 10 most frequent:
Groupe Francais De Pneumo-Cancerologie is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Groupe Francais De Pneumo-Cancerologie has 8 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
68 of the studies in Carcinoma, Non-Small-Cell Lung with a site in France that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT06430866Phase 3AmgenPharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) | 2026-12-14 |
| NCT03774732Phase 3UNICANCERPD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer | 2026-12-22 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
Among the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concomitant radio-chemotherapy and consolidation immunotherapy (cRT-CT+IO)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Sequential radio-chemotherapy and consolidation immunotherapy (sRT-CT+IO)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Concomitant radio-chemotherapy (cRT-CT)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Sequential radio-chemotherapy (sRT-CT)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Chemotherapy only (CT)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Chemotherapy plus immunotherapy (CT+IO)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Radiation therapy only (RT)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Immunotherapy only (IO)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Targeted therapy only (TT)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Best supportive care only (BSC)
Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
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
Also known as: Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), 5-level EuroQoL EQ5D (EQ5D-5L)
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.
Time frame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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.
Time frame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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.
Time frame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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)
Time frame: At Baseline
Tumor characteristics as defined by TNM stage
Characterize the stage III unresectable NSCLC patients by TNM stage according to the 8th TNM IASLC edition
Time frame: At Baseline
Tumor characteristics as defined by PD-L1 expression status
Characterize the stage III unresectable NSCLC patients by PD-L1 expression status (tumor propensity score)
Time frame: At Baseline
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 \[NRTK\])
Time frame: At Baseline
Time from diagnosis to treatment
Time frame: 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
Modality of follow-up
Description of modality of follow-up (e.g. type of imagery used, frequency of medical visit)
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
Treatment characteristics
Describe the chemotherapy, radiation therapy and immunotherapy protocols used (e.g. dose, reduction, interruptions, duration)
Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
Best response of treatment
Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
Duration of response of treatment
Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
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)
Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision
Concordance between effective treatment compared to initial MDTB decision
Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
Type of progression (local, loco-regional, metastatic)
Time frame: At date of first documented progression, assessed up to 5 years maximum
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
Time frame: From date of first documented progression up to end of study, assessed up to 5 years maximum
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
Time frame: 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
Evaluate the cost-utility of the therapeutic strategy using Quality-Adjusted Life Years (QALYs)
Time frame: 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
Plan to share: No — All collected data that underlie results in a publication
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Jun 2027, 78 months after the start.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 78 months is above that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Groupe Francais De Pneumo-Cancerologie