Clinical and biological data collection for metastatic lung cancer
Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients
This project will test whether a prospective database that combines clinical, imaging, psychological and multi-omic information can help predict which treatments will work best for people with metastatic lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Drugs / interventions | atezolizumab, durvalumab, pembrolizumab, bevacizumab, chemotherapy |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT04944030 on ClinicalTrials.gov |
What this trial studies
This prospective cohort enrolls first-line metastatic or locally advanced lung cancer patients and collects detailed clinical, epidemiological, psychological, imaging, biological and biopathological data, including a biopsy of metastatic lesions. Patients are categorized by histology and PD-L1/immunohistochemistry phenotypes (including SCLC and NSCLC subtypes) and receive standard-of-care systemic treatments guided by current national recommendations. Multi-omic analyses and in silico modeling will be applied to the integrated dataset to develop algorithms aimed at predicting treatment response and mechanisms of resistance. The study combines routine care data with research assays and patient questionnaires at two regional cancer centers.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic or locally advanced lung cancer not eligible for curative local treatment, WHO performance status ≤2, able to give informed consent and to undergo biopsy, blood sampling and scheduled follow-up visits are eligible.
Not a fit: Patients with early-stage disease, those unwilling or unable to undergo biopsy or required follow-up, or those with recent other malignancies as defined by the criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the project could enable more personalized treatment choices by identifying which patients are most likely to benefit from specific therapies and by reducing exposure to ineffective treatments.
How similar studies have performed: Similar prospective multi-omic and clinico-biological databases in lung and other cancers have shown promising signals for predictive modeling but have not yet become standard clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood sample and questionnaires * 18 years old at time of written consent * Patient with histologically confirmed lung cancer * Lung cancer metastatic disease or locally advanced not eligible for local curative treatment intent * Performance status ≤ 2 (according to WHO criteria) * Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Patient must be affiliated to a Social Health Insurance Exclusion Criteria: * Other malignancy treated within the last 3 years (except non-melanoma skin cancer or in situ carcinoma of the cervix) * Other neuroendocrine tumour than small cell or large cell carcinoma. * Pregnant or nursing patient * Individual deprived of liberty or placed under the authority of a tutor * Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
Where this trial is running
Angers and 1 other locations
- Institut de Cancerologie de L'Ouest — Angers, France (Recruiting)
- Institut de Cancerologie de L'Ouest — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: Judith Raimbourg, Md,phd — judith.raimbourg@ico.unicancer.fr
- Study coordinator: Judith Raimbourg, Md,phd
- Email: judith.raimbourg@ico.unicancer.fr
- Phone: 0240679900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.