Lung NeoplasmsNCT04566432
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients
An observational study of Lung Neoplasms and Lung Cancer, Nonsmall Cell, run by Geneplus-Beijing Co. Ltd. at 1 site in China.
Trial summary
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung
- What is being tested?
- Observation
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2025
- 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: treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma
Who may be able to join
- Provision of informed consent
- Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or 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
- No EGFR mutation in tissue and ctDNA
- Received immune checkpoint inhibitors as the first line therapy
- 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
1 site in 1 country.
About this study
Official title: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
Read the detailed description
In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of 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
- Being tested
- Observation
- Keywords
- Next Generation Sequencing (NGS), Liquid biopsy, Immune Checkpoint Inhibitor, Whole Transcriptome Sequencing
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
observe the association of ctDNA with efficacy of treatment
| Study group | Role | What they receive |
|---|---|---|
| Immune checkpoint inhibitors | Not described Receives: Other: Observation | |
| Targeted therapy | Targeting ALK, ROS1, MET ex14 skipping Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the evolution of ctDNA mutation profile during treatment
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
Measured: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)
Secondary outcomes (1)
Resistant mechanisms of targeted therapy
Resistant mutations will be identified from ctDNA or tissue mutations
Measured: At the time of disease progression (through study completion, an average of 1.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566432
- Sponsor's protocol ID
- TRACELib002
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
- ClinicalTrials.gov ID
- NCT04566432
- Acronym / sponsor ID
- TRACELib002
- Conditions
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Keywords
- Next Generation Sequencing (NGS), Liquid biopsy, Immune Checkpoint Inhibitor, Whole Transcriptome Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Sep 2020 (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 predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
Detailed description
In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune checkpoint inhibitors | – | Other: Observation |
| Targeted therapy | – | Other: ObservationTargeting ALK, ROS1, MET ex14 skipping |
Who may qualify
- Ages
- 18 years and older
- 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
Key inclusion criteria (6 listed)
- Provision of informed consent
- Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or 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
- No EGFR mutation in tissue and ctDNA
- Received immune checkpoint inhibitors as the first line therapy
- ECOG performance status 0-2 with expected more than 6 months of survival time
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationobserve the association of ctDNA with efficacy of treatment | Other | Immune checkpoint inhibitors, Targeted therapy |
Primary outcome
the evolution of ctDNA mutation profile during treatment
Time frame: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
1 secondary outcome
Resistant mechanisms of targeted therapy
Time frame: At the time of disease progression (through study completion, an average of 1.5 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 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Lung Neoplasms and Lung Cancer, Nonsmall Cell, run by Geneplus-Beijing Co. Ltd. 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 6 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 29 Jun 2026. 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?
the evolution of ctDNA mutation profile during treatment (time frame: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)). 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 29 Jun 2026.