Non-small Cell Lung Cancer Stage IIINCT02418234
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
An observational study of Non-small Cell Lung Cancer Stage III and Non-Small-Cell Lung Cancer Metastatic, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III, Non-Small-Cell Lung Cancer Metastatic
- What is being tested?
- mutation detection, ARMS and ddPCR and ctDNA analysis
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (NSCLC) after EGFR-TKI failure
Who may be able to join
- Histologically confirmed stage IIIB/IV NSCLC.
- Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
- Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- Patient must be able to comply with the protocol
Who cannot join
- Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
- Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- Histologically confirmed small cell lung cancer or other metastatic tumors
- Patient with no histologic or cytological diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
Read the detailed description
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure
- Being tested
- mutation detection, ARMS and ddPCR, ctDNA analysis
- Keywords
- Non-small Cell Lung Cancer, circulating tumor DNA, T790M, amplification refractory mutation system, digital droplet PCR
- 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.
mutation detectionOther
ARMS and ddPCROther
ctDNA analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).
Measured: up to 2 years
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
Measured: up to 2 years
Secondary outcomes (2)
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure
The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.
Measured: up to 2 years
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure
The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418234
- Sponsor's protocol ID
- HZFH CA15-02
- Status last verified
- Jan 2018
- First submitted
- 3 Apr 2015
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study
- ClinicalTrials.gov ID
- NCT02418234
- Acronym / sponsor ID
- HZFH CA15-02
- Keywords
- Non-small Cell Lung Cancer, circulating tumor DNA, T790M, amplification refractory mutation system, digital droplet PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
Detailed description
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 (NSCLC) after EGFR-TKI failure
Key inclusion criteria (4 listed)
- Histologically confirmed stage IIIB/IV NSCLC.
- Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
- Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- Patient must be able to comply with the protocol
Key exclusion criteria (4 listed)
- Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
- Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- Histologically confirmed small cell lung cancer or other metastatic tumors
- Patient with no histologic or cytological diagnosis.
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 |
|---|---|---|
| mutation detection | Other | – |
| ARMS and ddPCR | Other | – |
| ctDNA analysis | Genetic | – |
Primary outcome
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
Time frame: up to 2 years
The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
Time frame: up to 2 years
The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
2 secondary outcomes
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure
Time frame: up to 2 years
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Non-small Cell Lung Cancer Stage III and Non-Small-Cell Lung Cancer Metastatic, run by First People's Hospital of Hangzhou at 1 site in China.
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 4 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 12 Mar 2018. 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 China. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 12 Mar 2018.