Lung CancerOS-TUMOVASCNCT05136014
Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
An observational study of Lung Cancer and Lung Adenocarcinoma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Adenocarcinoma, EGFR Activating Mutation
- What is being tested?
- Collection of surgical waste
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 1 Nov 2022
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital
Who may be able to join
- age 18 years or older
- patient affiliated to a social security scheme
- having given their agreement to participate in the study
- with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital
Who cannot join
- Refusal to participate
- Hepatitis
- HIV
- Legal guardianship
- Guardianship
- Inability to give informed information to the patient
- Pregnant women-
Trial locations and contacts
1 site in 1 country.
About this study
Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Its prognosis remains poor despite the emergence of new therapies, notably the Epithelial Growth Factor Receptor (EGFR) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of EGFR.
In addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. In addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (ADAURA trial). For this reason, we have proposed tests using TKIs on an in vitro platform based on organoid formation from tumour biopsies of NSCLC patients. This model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. In this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the INCA (4-6 weeks).
For non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. This model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.
- Conditions
- Lung Cancer, Lung Adenocarcinoma, EGFR Activating Mutation, KRAS Mutation-Related Tumors, Non Small Cell Lung Cancer
- Being tested
- Collection of surgical waste
- Keywords
- tyrosine kinase inhibitors, Lung adenocarcinoma, EGFR activating mutation, KRAS Mutation-related tumors
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of surgical wasteOther
collection of a fragment of healthy and tumorous lung tissue taken as part of the operating theatre procedure and normally destined to be destroyed
| Study group | Role | What they receive |
|---|---|---|
| General cohorte | patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU Receives: Other: Collection of surgical waste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination
Cell viability test
Measured: from day 0 to day 30
Secondary outcomes (1)
Identify non-responders to osimertinib in vitro
Cell viability test
Measured: from day 0 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de Lorraine
- Responsible party
- Principal investigator, SEITLINGER Joseph, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136014
- Sponsor's protocol ID
- 2021PI057
- Acronym
- OS-TUMOVASC
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 26 Nov 2021
- 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 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
- ClinicalTrials.gov ID
- NCT05136014
- Acronym / sponsor ID
- OS-TUMOVASC / 2021PI057
- Conditions
- Lung Cancer, Lung Adenocarcinoma, EGFR Activating Mutation, KRAS Mutation-Related Tumors, Non Small Cell Lung Cancer
- Keywords
- tyrosine kinase inhibitors, Lung adenocarcinoma, EGFR activating mutation, KRAS Mutation-related tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de Lorraine
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 26 Nov 2021 (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.
Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Its prognosis remains poor despite the emergence of new therapies, notably the Epithelial Growth Factor Receptor (EGFR) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of EGFR.
In addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. In addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (ADAURA trial). For this reason, we have proposed tests using TKIs on an in vitro platform based on organoid formation from tumour biopsies of NSCLC patients. This model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. In this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the INCA (4-6 weeks).
For non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. This model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General cohorte | – | Other: Collection of surgical wastepatient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital
Key inclusion criteria (4 listed)
- age 18 years or older
- patient affiliated to a social security scheme
- having given their agreement to participate in the study
- with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital
Key exclusion criteria (7 listed)
- Refusal to participate
- Hepatitis
- HIV
- Legal guardianship
- Guardianship
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 |
|---|---|---|
| Collection of surgical wastecollection of a fragment of healthy and tumorous lung tissue taken as part of the operating theatre procedure and normally destined to be destroyed | Other | General cohorte |
Primary outcome
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination
Time frame: from day 0 to day 30
Cell viability test
1 secondary outcome
Identify non-responders to osimertinib in vitro
Time frame: from day 0 to day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer and Lung Adenocarcinoma, run by Central Hospital, Nancy, France 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 7 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: status not confirmed, as of the sponsor's last update on 26 Nov 2021. 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?
Results are not available in the source record.
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?
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination (time frame: from day 0 to day 30). 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 26 Nov 2021.