Non Small Cell Lung CancerRESTKINCT04546282
Resistance to Oral Therapy in Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Description of the molecular alterations detected in blood samples of patients treated by osimertinib
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 28 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic adenocarcinoma
Who may be able to join
- advanced non-small cell lung cancer stage IIIB/IV
- Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
- Patient may receive up to one line of third EGFR TKI
- Plasma sample testing performed to detect EGFR TKI resistance
Who cannot join
- Patients have other concurrent cancers
- Patients who are not eligible receive TKI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Resistance to 3rd Generation Thyrosine Kinase Inhibitors in Lung Cancer
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.
These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.
Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Description of the molecular alterations detected in blood samples of patients treated by osimertinib
- Keywords
- 3rd Tyrosine kinase inhibitor, Cell free DNA, Mutations
- 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.
Description of the molecular alterations detected in blood samples of patients treated by osimertinibOther
Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib treated patients | Patients with metastatic adenocarcinoma of the lung for whom a 3rd generation TKI therapy is proposed and a search for resistance mutation by blood analysis as part of the usual management. Receives: Other: Description of the molecular alterations detected in blood samples of patients treated by osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features.
This retrospective study will collate the molecular alterations detected during routine analysis. The elements extracted from the file will be age, sex, type of tumor and clinical-histological characteristics, dates of diagnosis and start of treatment. In addition, information on the dates of appearance of resistances (radiographic or clinical) will also be provided.
No additional analysis will be performed since the study will consist of the analysis of data generated by the analyses performed in the context of patient management and biological monitoring.
This research does not aim to modify your care. There will be no additional consultation or examination, nor will there be any changes in the treatment prescribed by your doctor.
Measured: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.
Secondary outcomes (1)
Frequency of detected molecular alterations
Frequency of detected molecular alterations
Measured: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jul 2017
- Primary completion1 Jul 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome Solassol, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546282
- Sponsor's protocol ID
- RECHMPL20_0519
- Acronym
- RESTKI
- Status last verified
- Dec 2020
- First submitted
- 4 Sep 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Resistance to 3rd Generation Thyrosine Kinase Inhibitors in Lung Cancer
- ClinicalTrials.gov ID
- NCT04546282
- Acronym / sponsor ID
- RESTKI / RECHMPL20_0519
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- 3rd Tyrosine kinase inhibitor, Cell free DNA, Mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.
These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.
Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osimertinib treated patients | – | Other: Description of the molecular alterations detected in blood samples of patients treated by osimertinibPatients with metastatic adenocarcinoma of the lung for whom a 3rd generation TKI therapy is proposed and a search for resistance mutation by blood analysis as part of the usual management. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic adenocarcinoma
Key inclusion criteria (4 listed)
- advanced non-small cell lung cancer stage IIIB/IV
- Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
- Patient may receive up to one line of third EGFR TKI
- Plasma sample testing performed to detect EGFR TKI resistance
Key exclusion criteria (2 listed)
- Patients have other concurrent cancers
- Patients who are not eligible receive TKI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of the molecular alterations detected in blood samples of patients treated by osimertinibDescription of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay. | Other | Osimertinib treated patients |
Primary outcome
Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features.
Time frame: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.
This retrospective study will collate the molecular alterations detected during routine analysis. The elements extracted from the file will be age, sex, type of tumor and clinical-histological characteristics, dates of diagnosis and start of treatment. In addition, information on the dates of appearance of resistances (radiographic or clinical) will also be provided. No additional analysis will be performed since the study will consist of the analysis of data generated by the analyses performed in the context of patient management and biological monitoring. This research does not aim to modify your care. There will be no additional consultation or examination, nor will there be any changes in the treatment prescribed by your doctor.
1 secondary outcome
Frequency of detected molecular alterations
Time frame: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Solassol study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features. (time frame: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2020.