Non-small Cell Lung Cancer Stage IIINCT02623257
EGFR Mutations on ctDNA in Patients With Advanced NSCLC
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 study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens. 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 ctDNA analysis
- How many people
- 1,055 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2017
- 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 (NSCLC)
Who may be able to join
- Histologically confirmed stage IIIB/IV NSCLC;
- Patient had received ≤ 1 prior systemic chemotherapy regimens;
- Provision of blood (plasma) sample for ctDNA testing;
- Patient must be able to comply with the protocol;
Who cannot join
- Prior received ≥2 systemic chemotherapy regimens;
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
- 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: A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer
The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.
- Being tested
- mutation detection, ARMS, ctDNA analysis
- Keywords
- Non-small Cell Lung Cancer, circulating tumor DNA, amplification refractory mutation system
- 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
ARMSOther
ctDNA analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)
Measured: up to 2 years
Secondary outcomes (3)
Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics
The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage
Measured: up to 2 years
Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in treatment-naive patients with non-small cell lung cancer (NSCLC)
Measured: up to 2 years
Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in non-small cell lung cancer (NSCLC) patients after first-line chemotherapy 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 posted7 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionDec 2017
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 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
- 1,055 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
- NCT02623257
- Sponsor's protocol ID
- 20154701
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02623257
- Acronym / sponsor ID
- 20154701
- Keywords
- Non-small Cell Lung Cancer, circulating tumor DNA, amplification refractory mutation system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,055 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Dec 2015 (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 study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.
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)
Key inclusion criteria (4 listed)
- Histologically confirmed stage IIIB/IV NSCLC;
- Patient had received ≤ 1 prior systemic chemotherapy regimens;
- Provision of blood (plasma) sample for ctDNA testing;
- Patient must be able to comply with the protocol;
Key exclusion criteria (4 listed)
- Prior received ≥2 systemic chemotherapy regimens;
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
- 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 | Other | – |
| ctDNA analysis | Genetic | – |
Primary outcome
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time frame: up to 2 years
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)
3 secondary outcomes
Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics
Time frame: up to 2 years
Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time frame: up to 2 years
Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time frame: up to 2 years
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 13 Feb 2018.
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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 13 Feb 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?
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?
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay (time frame: up to 2 years). 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 13 Feb 2018.