Lung CancerALCAPONENCT02281214
NGS Genome Analysis in Personalisation of Lung Cancer Treatment
A study testing blood sample, biopsy in people with Lung Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- blood sample, biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2014to 17 Nov 2018
- Phase
- Interventional
- 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
Who may be able to join
- patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
- Patients with epidermoid cancer of the lungs can benefit from chemotherapy
- man and women
- age ≥ 18 years
- Patients have signed a written informed consent form
- Patients are affiliated to s social health insurance
Who cannot join
- Survival time ≤ 3 months
- Patients with cerebral metastases
- Patients could not benefit from treatment for others diseases
- Pregnancy or breast-feeding
- Incapacity to sign the consent form for psychiatric, behavioural disorders
- Private individuals of freedom or under tutelage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment
The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.
- Conditions
- Lung Cancer
- Being tested
- blood sample, biopsy
- Keywords
- lung cancer, mutations, patients, mutations
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample, biopsyOther
Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis
| Study group | Role | What they receive |
|---|---|---|
| blood sample, biopsy | Experimental | Not described Receives: Other: blood sample, biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS
Measured: search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy)
Secondary outcomes (2)
comparison of genome profiles (mutations and rearrangements)
To compare gene profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) in primary lung tumors before treatment and when tumor progression on therapy according to treatment groups (targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation) using NGS methods
Measured: comparison of genome profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, ...mutations and ALK , ROS rearrangements) between targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation
tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) and circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements)
Measured: To compare tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) with circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, ...mutations and rearrangements using NGS methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study start24 Oct 2014
- Primary completion17 Nov 2014
- Study completion17 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno COUDERT, MD, PhD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281214
- Sponsor's protocol ID
- 2014-A01163-44
- Acronym
- ALCAPONE
- Status last verified
- Dec 2018
- First submitted
- 23 Oct 2014
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalens L, Niogret J, Richard C, Chevrier S, Foucher P, Coudert B, Lagrange A, Favier L, Westeel V, Kim S, Adotevi O, Chapusot C, Martin L, Arnould L, Kaderbhai CG, Boidot R. Durable response of lung carcinoma patients to EGFR tyrosine kinase inhibitors is determined by germline polymorphisms in some immune-related genes. Mol Cancer. 2023 Jul 29;22(1):120. doi: 10.1186/s12943-023-01829-4.
PubMed 37516818
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment
- ClinicalTrials.gov ID
- NCT02281214
- Acronym / sponsor ID
- ALCAPONE / 2014-A01163-44
- Conditions
- Lung Cancer
- Keywords
- lung cancer, mutations, patients, mutations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 17 Nov 2014 (actual)
- Study completion
- 17 Nov 2018 (actual)
- First posted
- 3 Nov 2014 (estimated)
- 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.
The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample, biopsy | Experimental | Other: blood sample, biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
- Patients with epidermoid cancer of the lungs can benefit from chemotherapy
- man and women
- age ≥ 18 years
- Patients have signed a written informed consent form
Key exclusion criteria (6 listed)
- Survival time ≤ 3 months
- Patients with cerebral metastases
- Patients could not benefit from treatment for others diseases
- Pregnancy or breast-feeding
- Incapacity to sign the consent form for psychiatric, behavioural disorders
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 |
|---|---|---|
| blood sample, biopsyBlood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis | Other | blood sample, biopsy |
Primary outcome
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS
Time frame: search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy)
2 secondary outcomes
comparison of genome profiles (mutations and rearrangements)
Time frame: comparison of genome profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, ...mutations and ALK , ROS rearrangements) between targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation
tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) and circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements)
Time frame: To compare tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) with circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, ...mutations and rearrangements using NGS methods
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 4 Jan 2019.
- Derived from this study: PubMed 37516818Dalens L, Niogret J, Richard C, Chevrier S, Foucher P, Coudert B, Lagrange A, Favier L, Westeel V, Kim S, Adotevi O, Chapusot C, Martin L, Arnould L, Kaderbhai CG, Boidot R. Durable response of lung carcinoma patients to EGFR tyrosine kinase inhibitors is determined by germline polymorphisms in some immune-related genes. Mol Cancer. 2023 Jul 29;22(1):120. doi: 10.1186/s12943-023-01829-4.
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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.
Bruno COUDERT, MD, PhD principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, biopsy in people with Lung Cancer, run by Centre Georges Francois Leclerc 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 6 inclusion and 6 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 4 Jan 2019. 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?
search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS (time frame: search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281214, which also lists 1 linked publication.
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 4 Jan 2019.