Non-small Cell Lung CancerNCT05648370
Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
An observational study of Non-small Cell Lung Cancer and Oligometastatic Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Oligometastatic Disease
- What is being tested?
- ctDNA testing and whole exome sequencing
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 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: Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or oligoprogression or oligorelapses after systemic therapy
Who may be able to join
- Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
- Patients must be a man or woman of more than 18 years;
- ECOG PS ≦1；
- The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
- The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; [Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.
- Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.
Show all 9Show fewer
- Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.
- Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.]
- Lesion evaluation can be surgically removed. [Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.]
Who cannot join
- Patients with a confirmed or suspected autoimmune disease;
- Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
- Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
- Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
- Patients with a history of other malignancies in the past 5 years;
- Patients identified by the investigators patients with contraindications to local treatment;
Show all 9Show fewer
- Patients with serious mental illness;
- Patients who cannot sign informed consent;
- Patients who cannot be followed up as scheduled;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Wen-Zhao Zhong, Ph.D, +86 02083827812, syzhongwenzhao@scut.edu.cn
Rui Fu, M.D., +86 02083827812, ruifu66@foxmail.com
About this study
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.
Read the detailed description
60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.
- Being tested
- ctDNA testing and whole exome sequencing
- 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.
ctDNA testing and whole exome sequencingGenetic
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.
| Study group | Role | What they receive |
|---|---|---|
| oligometastatic disease | Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis. Receives: Genetic: ctDNA testing and whole exome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between perioperative ctDNA-MRD characteristics and rogression-free survival
To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years.
Measured: 2-year PFS
Construction of a survival-prediction model
The survival-prediction model based on clinicopathological and genomic characteristics.
Measured: Through study completion, up to 5 years
Secondary outcomes (5)
Association among ctDNA status before surgery, systemic treatment times, and survival
To explore the potential association among plasma ctDNA status surgery, systemic treatment time duration, PFS and OS.
Measured: Through study completion, up to 5 years
Genomic characteristics and clonal evolution after systemic treatment
Using whole-exome sequencing to identify genomic characteristics and clonal evolution after systemic treatment
Measured: Through study completion, up to 5 years
Potential drug-resistance mechanism identified by plasma ctDNA
Using plasma ctDNA-MRD to identify the potential drug-resistance mechanism.
Measured: Through study completion, up to 5 years
Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery
Association among perioperative ctDNA-MRD characteristics, imaging response, and pathological response.
Measured: 60 patients underwent surgery
Heterogeneity in Genomic and transcriptome between primary and metastatic tumors
Using whole-exome sequencing and whole transcriptome sequencing to identify genomic and transcriptome heterogeneity between primary and metastatic tumors.
Measured: 60 patients underwent surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Zhao Zhong, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648370
- Sponsor's protocol ID
- LB4S
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
- ClinicalTrials.gov ID
- NCT05648370
- Acronym / sponsor ID
- LB4S
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Dec 2022 (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.
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.
Detailed description
60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oligometastatic disease | – | Genetic: ctDNA testing and whole exome sequencingDynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or oligoprogression or oligorelapses after systemic therapy
Key inclusion criteria (9 listed)
- Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
- Patients must be a man or woman of more than 18 years;
- ECOG PS ≦1；
- The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
- The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; [Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.
Key exclusion criteria (9 listed)
- Patients with a confirmed or suspected autoimmune disease;
- Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
- Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
- Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
- Patients with a history of other malignancies in the past 5 years;
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 |
|---|---|---|
| ctDNA testing and whole exome sequencingBlood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing. | Genetic | oligometastatic disease |
Primary outcome
Association between perioperative ctDNA-MRD characteristics and rogression-free survival
Time frame: 2-year PFS
To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years.
Construction of a survival-prediction model
Time frame: Through study completion, up to 5 years
The survival-prediction model based on clinicopathological and genomic characteristics.
5 secondary outcomes
Association among ctDNA status before surgery, systemic treatment times, and survival
Time frame: Through study completion, up to 5 years
Genomic characteristics and clonal evolution after systemic treatment
Time frame: Through study completion, up to 5 years
Potential drug-resistance mechanism identified by plasma ctDNA
Time frame: Through study completion, up to 5 years
Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery
Time frame: 60 patients underwent surgery
Heterogeneity in Genomic and transcriptome between primary and metastatic tumors
Time frame: 60 patients underwent surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Wen-Zhao Zhong, Ph.D principal investigator
Guangdong Provincial People's Hospital
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 and Oligometastatic Disease, run by Guangdong Provincial People's Hospital 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Zhao Zhong, Ph.D (+86 02083827812, syzhongwenzhao@scut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between perioperative ctDNA-MRD characteristics and rogression-free survival (time frame: 2-year PFS). 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 13 Dec 2022.