Lung NeoplasmsNCT03059641
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
An observational study of Lung Neoplasms and Lung Cancer, Nonsmall Cell, run by Geneplus-Beijing Co. Ltd. at 14 sites in China.
Trial summary
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung
- How many people
- 300 participants
- Where
- 14 sitesChina
- Study dates
- 22 Feb 2017to 30 Jan 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma without smoking history
Who may be able to join
- Provision of informed consent
- Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
- ECOG performance status 0-2 with expected more than 6 months of survival time
- Willingness to comply with required protocols and give permission to use the data for clinical research and products development
Who cannot join
- Patients have other primary cancers
- Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
- Patients failed in either plasma or tissue sample QC
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
First Hospital of Jilin University
Changchun
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Sir Run Run Shaw Hospital, Zhejiang University School of medicine
Hangzhou
The First Hospital of Zhejiang Province
Hangzhou
Anhui Provincial Hospital
Hefei
Jiangsu Jiangyin People's Hospital
Jiangyin
The Second Affiliated Hospital of Nanchang University
Nanchang
Ningbo No.2 Hospital
Ningbo
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Changzheng Hospital
Shanghai
Shanghai Chest Hospital
Shanghai
Shanghai East Hospital
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Affiliated Hospital, Jiangnan University
Wuxi
About this study
Official title: Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.
Read the detailed description
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.
- Conditions
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Keywords
- Next Generation Sequencing (NGS), Tyrosine Kinase Inhibitor (TKI), liquid biopsy, EGFR Gene mutation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
Measured: 2 years
Secondary outcomes (1)
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start22 Feb 2017
- Primary completion31 Dec 2019
- Study completion30 Jan 2020
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 NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059641
- Sponsor's protocol ID
- TRACELib-NSCLC
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai X, Cui J, Zhang J, Chen R, Lin W, Xie C, Liu A, Zhang J, Yang W, Hu X, Hu X, Zhao Q, Rao C, Zang YS, Ning R, Li P, Chang L, Yi X, Lu S. Clonal Architecture of EGFR Mutation Predicts the Efficacy of EGFR-Tyrosine Kinase Inhibitors in Advanced NSCLC: A Prospective Multicenter Study (NCT03059641). Clin Cancer Res. 2021 Feb 1;27(3):704-712. doi: 10.1158/1078-0432.CCR-20-3063. Epub 2020 Nov 13.
PubMed 33188140
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
- ClinicalTrials.gov ID
- NCT03059641
- Acronym / sponsor ID
- TRACELib-NSCLC
- Conditions
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Keywords
- Next Generation Sequencing (NGS), Tyrosine Kinase Inhibitor (TKI), liquid biopsy, EGFR Gene mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 23 Feb 2017 (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.
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.
Detailed description
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma without smoking history
Key inclusion criteria (4 listed)
- Provision of informed consent
- Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
- ECOG performance status 0-2 with expected more than 6 months of survival time
- Willingness to comply with required protocols and give permission to use the data for clinical research and products development
Key exclusion criteria (3 listed)
- Patients have other primary cancers
- Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
- Patients failed in either plasma or tissue sample QC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
Time frame: 2 years
1 secondary outcome
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
Time frame: 1 year
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 5 Feb 2020.
- Derived from this study: PubMed 33188140Ai X, Cui J, Zhang J, Chen R, Lin W, Xie C, Liu A, Zhang J, Yang W, Hu X, Hu X, Zhao Q, Rao C, Zang YS, Ning R, Li P, Chang L, Yi X, Lu S. Clonal Architecture of EGFR Mutation Predicts the Efficacy of EGFR-Tyrosine Kinase Inhibitors in Advanced NSCLC: A Prospective Multicenter Study (NCT03059641). Clin Cancer Res. 2021 Feb 1;27(3):704-712. doi: 10.1158/1078-0432.CCR-20-3063. Epub 2020 Nov 13.
- 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.
Shun Lu, MD principal investigator
Shanghai Chest Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Lung Cancer, Nonsmall Cell, run by Geneplus-Beijing Co. Ltd. at 14 sites 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 3 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment. (time frame: 2 years). 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 NCT03059641, 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 5 Feb 2020.