Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA (NCT03926260) | Clinical Trial Compass
CompletedNot Applicable
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
France100 participantsStarted 2019-06-27
Plain-language summary
In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.
Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.
An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
* At least one measurable target according to RECIST criteria
* Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
* Performance Status 0 to 2
* Affiliated to a social security system
* Patient who can be followed under the protocol
* Patient agreed to participate in the study and gave his/her express consent
Exclusion Criteria:
* Minor
* Small cell or mixed bronchial cancer
* Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
* Patient who has already started a first line of treatment
* Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
* History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
* Patient which, does present a substantial risk of recurrence.
* Major under guardianship, curators or deprived of liberty
* Pregnant or lactating woman, or of childbearing age without effective contraception
* Not affiliated to a social security system
* Inability to understand the protocol and / or to give express consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biological response at week 3
Timeframe: week 3 after patient's recruitment date (baseline)