An interventional study of Blood Sampling (2*8mL Tubes) and PBMC Sampling (1*8mL Tubes) in Lung Cancer, Carcinoma, Non-Small-Cell Lung and Small Cell Lung Carcinoma, sponsored by Nantes University Hospital. Recruiting at 4 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Basic science
In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).
In parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 730 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Patients :
Healthy subjects :
Ancillary Study :
-Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination.
Exclusion Criteria:
Patients :
Healthy subjects :
Ancillary Study :
- Pregnant or breast-feeding women
Patients are prospectively enrolled the day before their surgery for lung cancer, following selection based on tumor size assessed by the latest CT scan. The lesion size must be ≥ 20 mm (to prioritize anatomopathological analyses performed as part of care). If patients receive adjuvant treatment, blood samples will be collected on the day of treatment initiation and during follow-up. Patients receiving neoadjuvant treatment will be enrolled at the time of their first consultation with the medical oncologist. Patients in this cohort must meet the following criteria: \- Stage I / II / IIIA-B localized NSCLC (non-small-cell lung cancer) eligible for surgery and adjuvant or neoadjuvant therapy (15-20% of NSCLC) Intervention : patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
Other: Blood Sampling (2*8mL Tubes)
Patients are prospectively enrolled at the diagnosis of lung neoplasm, during the establishment of the therapeutic plan by the referring oncologist or pneumo-oncologist. Enrollment can also occur at the initiation of first-line treatment if it was not done at the time of the diagnostic consultation. Patients in this cohort must meet the following criteria: \- metastatic NSCLC or SCLC (small-cell bronchial cancers), with drained or punctured pleural effusion and anatomopathological evidence of tumor cells Intervention, the following volumes of blood will be drawn at each visit : * 2\*8ml (EDTA tubes) * 1\*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1\*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Other: Blood Sampling (2*8mL Tubes) · Other: PBMC Sampling (1*8mL Tubes) · Other: Paxgene Sampling
Cohort C patients are recruited in the same way as for cohort B. Patients in this cohort must meet the following criteria: * Metastatic NSCLC receiving systemic chemotherapy, immunotherapy and/or targeted therapy * Locally advanced stage III NSCLC treated with radio-chemotherapy +/- immunotherapy * Extra-thoracic SCLC treated with chemotherapy +/- immunotherapy * Intra-thoracic SCLC treated with radio-chemotherapy Intervention, the following volumes of blood will be drawn at each visit : * 2\*8ml (EDTA tubes) * 1\*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1\*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Other: Blood Sampling (2*8mL Tubes) · Other: PBMC Sampling (1*8mL Tubes) · Other: Paxgene Sampling
Patients are enrolled preoperatively, at the diagnosis of metastatic lung cancer at the cerebral level. The patient signs consent preoperatively (consent provided by the neurosurgeon). Subsequently, they are prospectively followed as part of their management in medical oncology, postoperatively. Patients in this cohort must meet the following criteria: \- Patient operated on for brain metastasis as part of care, and diagnosed with lung cancer. Intervention, the following volumes of blood will be drawn at each visit : * 2\*8ml (EDTA tubes) * 1\*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1\*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Other: Blood Sampling (2*8mL Tubes) · Other: PBMC Sampling (1*8mL Tubes) · Other: Paxgene Sampling
A population of healthy subjects will also be included. These healthy subjects will be either : * Companions of patients with lung cancer who have come to the oncology clinic for their loved ones. * Patients who have undergone atypical lung resection as part of their care for pneumothorax. Intervention : Healthy subject will be sampled from 2 x 8 mL blood tubes (EDTA tubes) In addition to blood samples from healthy subjects, healthy tissue remnants from atypical lung resections performed as part of care for pneumothorax management will be used to analyze the study objectives. A maximum of 30 healthy subjects are expected in this population.
Other: Blood Sampling (2*8mL Tubes)
Patients included in the other arms of the cohort may also participate in the ancillary study if they meet the following conditions : Being carriers of metastatic KRAS G12C mutated NSCLC with a treatment plan involving sotorasib, adagrasib, or another KRAS inhibitor, either alone or in combination with another treatment. A target of 40 patients (among the 700 patients included in the cohort, excluding healthy subjects) is set for the ancillary study.
Procedure: Extended biopsies of tumor lesions
Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
Patients will be sampled from 1 x 8 mL PBMC
Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube
Regarding the ancillary study, as part of the care, patients are biopsied at diagnosis and during relapse(s). For metastatic patients with multiple sites, one site (the most accessible) is chosen and biopsied in interventional radiology or pulmonology. The material used is: 17-18G biopsy needle / Sampling chamber volume of 0.01 cm³ to 0.02 cm³. For a standard biopsy as part of the care, 3 samples are taken (total volume of 0.03 cm³ to 0.06 cm³). Inclusion in the ancillary study would add one sample using the same biopsy path, resulting in an additional volume of 0.01 cm³ to 0.02 cm³. In the case of a complex biopsy, no additional sampling related to the research will be performed.
Overall survival
Overall survival will be defined as the time elapsed between the date of the initial diagnosis of lung cancer and the date of death, regardless of the cause. Patients still alive at the end of the follow-up period will complete their participation in the cohort.
Time frame: up to 5 years
Describe the care pathway for patients with lung cancer. Assess the time intervals between different steps in the initial management of lung cancer.
The care pathway will be described through the collection of dates (surgery, radiotherapy, presentation at multidisciplinary consultation meetings, etc.) and types of medical consultations.
Time frame: up to 5 years
Evaluate the return to work for patients of working age who have been treated for lung cancer.
Proportion of patients who returned to work after treatment, measurement of the average time taken, and factors associated with the return to work.
Time frame: up to 5 years
Identify specific biomarkers of lung cancer cells (primary tumors or metastatic tissues) in comparison to healthy lung tissues.
Quantitative comparison and characterization of biomarkers (extracellular vesicles and miRNA signatures) between tumor tissues and non-cancerous tissues.
Time frame: up to 5 years
Evaluate the prognostic and predictive value of circulating biomarkers at diagnosis and during systemic treatments.
Association between levels of circulating biomarkers and overall survival as well as treatment response.
Time frame: up to 5 years
Predicting the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.
Time frame: up to 5 years
Determining the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.
Time frame: up to 5 years
Determining whether transcriptional changes under sotorasib or adagrasib can predict progression-free survival in patients with metastatic KRAS G12C-mutated NSCLC.
Time frame: up to 5 years
Assessing the prognostic value of detecting specific molecular alterations occurring under treatment.
Time frame: up to 5 years
Identifying whether new molecular alterations can be detected in tumor and plasma samples from patients at progression.
Time frame: up to 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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