Lung CancerNCT02827357
Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
An observational study of Lung Cancer, run by University Hospital, Toulouse.
Trial summary
This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. 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?
- No specific intervention
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Sep 2015
- 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 advanced nonsmall-cell lung cancer (NSCLC), a known HER2 exon-20 insertion, treated with chemotherapy and/or HER2-targeted drugs
Who may be able to join
- patients with advanced nonsmall-cell lung cancer
- known HER2 exon-20 insertion
- treated with chemotherapy and/or HER2-targeted drugs
Who cannot join
- none
About this study
Official title: Review of Responses to Systemic Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.
- Conditions
- Lung Cancer
- Being tested
- No specific intervention
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionOther
Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 24 months
Secondary outcomes (1)
Median progression-free survival (PFS) with conventional chemotherapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionSep 2015
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 University Hospital, ToulouseThe 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
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAZIERES Julien, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827357
- Sponsor's protocol ID
- 14 7305 03
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Responses to Systemic Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
- ClinicalTrials.gov ID
- NCT02827357
- Acronym / sponsor ID
- 14 7305 03
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Jul 2016 (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.
This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced nonsmall-cell lung cancer (NSCLC), a known HER2 exon-20 insertion, treated with chemotherapy and/or HER2-targeted drugs
Key inclusion criteria (3 listed)
- patients with advanced nonsmall-cell lung cancer
- known HER2 exon-20 insertion
- treated with chemotherapy and/or HER2-targeted drugs
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| No specific interventionClinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response | Other | – |
Primary outcome
Overall response rate
Time frame: 24 months
1 secondary outcome
Median progression-free survival (PFS) with conventional chemotherapy
Time frame: 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 11 Jul 2016.
- Individual participant dataSharing planned: No
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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.
MAZIERES Julien, MD PhD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University Hospital, Toulouse.
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 3 inclusion and 1 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall response rate (time frame: 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 11 Jul 2016.