NSCLCNCT03453307
Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients
An observational study of NSCLC, run by K2 Oncology, Inc. at 1 site in China.
Trial summary
This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2018to 30 Jul 2021
- 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
- Adult, Older adult
Study population: Metastatic NSCLC patients with axillary and other region lymph nodes metastasis. The biopsy and/or surgery tissue samples of metastatic and/or primitive tumor are accessible.
Who may be able to join
- Aged 18 years old or more;
- Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis;
- Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor;
- No clinical evidence of other malignancy, unstable complication or uncontrolled infection;
- Life expectancy > 12 months.
- Informed and signed consent by the patient.
Who cannot join
- Not accessible to biopsy and/or surgery sample;
- Patient already enrolled in another clinical trial with another first line of chemotherapy;
- Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria;
- Women who are pregnant, plan to become pregnant or are lactating during the study;
- Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found;
- Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies;
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- Have other malignant tumor previously;
- Have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions;
- State of health can't finish the study;
- Patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study.
- No self-determination or refuse to participant.
- With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Hebei Province
Shijiazhuang, Hebei, 050051
Lijun Liu, 18903391188, 13833131067@163.com
About this study
Official title: The Correlation Study of the Drug Sensitivity Between Ex Vivo Model of Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Organoids and Clinical Response in NSCLC Patients
This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.
Read the detailed description
Methods - Open label single arm observatory comparison experiment
- Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients.
- The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test.
- The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.
- Conditions
- NSCLC
- Keywords
- Tumor Organoids, Drug Sensitivity, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | NSCLC patients receiving chemotherapy or target therapy treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ex vivo sensitivity test on patient derived organoid models
The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start30 Jan 2018
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- K2 Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhijian Sun, Dr., Principal investigator, K2 Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453307
- Sponsor's protocol ID
- K2OLC-001
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Study of the Drug Sensitivity Between Ex Vivo Model of Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Organoids and Clinical Response in NSCLC Patients
- ClinicalTrials.gov ID
- NCT03453307
- Acronym / sponsor ID
- K2OLC-001
- Conditions
- NSCLC
- Keywords
- Tumor Organoids, Drug Sensitivity, NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- K2 Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 5 Mar 2018 (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.
This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.
Detailed description
Methods - Open label single arm observatory comparison experiment
- Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients.
- The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test.
- The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | –NSCLC patients receiving chemotherapy or target therapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Metastatic NSCLC patients with axillary and other region lymph nodes metastasis. The biopsy and/or surgery tissue samples of metastatic and/or primitive tumor are accessible.
Key inclusion criteria (6 listed)
- Aged 18 years old or more;
- Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis;
- Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor;
- No clinical evidence of other malignancy, unstable complication or uncontrolled infection;
- Life expectancy > 12 months.
Key exclusion criteria (12 listed)
- Not accessible to biopsy and/or surgery sample;
- Patient already enrolled in another clinical trial with another first line of chemotherapy;
- Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria;
- Women who are pregnant, plan to become pregnant or are lactating during the study;
- Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found;
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
Correlation of ex vivo sensitivity test on patient derived organoid models
Time frame: 12 months
The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
Zhijian Sun, Dr. principal investigator
K2 Oncology, Inc.
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 NSCLC, run by K2 Oncology, Inc. 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 12 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 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijian Sun, Dr. ((86) 18201013329, zjsun@k2oncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ex vivo sensitivity test on patient derived organoid models (time frame: 12 months). 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 5 Mar 2018.