Lung CancerPhase 2NCT05669586
Organoids Predict Therapeutic Response in Patients With Multi-line Drug-resistant Lung Cancer
A Phase 2 study testing Antitumor therapy guided by organoid drug sensitivity test in people with Lung Cancer and Organoid, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
This is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Organoid
- What is being tested?
- Antitumor therapy guided by organoid drug sensitivity test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 May 2026
- Phase
- Phase 2
- 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
Who may be able to join
- Male or female patients: ≥18 years old.
- For non-small cell lung cancer confirmed by histology or cytology, there is no standard protocol recommendation in the guidelines for disease progression after multiline standard therapy.
- Expected survival ≥3 months.
- Sign informed consent.
- The patient is willing and able to adhere to the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
- Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
- At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.
Who cannot join
- Participated in clinical trials of other drugs within four weeks.
- Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
- Not accessible to biopsy and/or surgery sample.
- Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
- For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
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- The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.
- Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders.
- The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid Reduced function; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included).
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
liu quan, doctor, 15995299079, quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com
liu quan, doctor
About this study
Official title: A Single-arm, Single-center Clinical Trial of Patient-derived Lung Cancer Organoids for Predicting Therapeutic Response in Patients With Multiline Drug-resistant Lung Cancer
This is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment regiments for patients with lung cancer who are resistant to multi-line standard therapies.
Read the detailed description
As for the difficult problem of drug resistance in lung cancer after multi-line therapy, there is no standard consensus in clinical diagnosis and treatment, and relevant treatment plans are still being explored and the efficacy is unknown. Patient-derived organoid cells (PDOs) have become a reliable tumor model for drugs in vitro. PDOs is a personalized tumor model with similar characteristics to the original tumor. This model can maintain the molecular and cellular composition of the original tumor, reflect the heterogeneity of the original tumor, and realize in vitro high-throughput rapid screening of drug sensitivity, accurately predict the drug response of patients, so as to provide rapid clinical drug feedback. In recent years, lung cancer organoids have also been rapidly established to reproduce the tissue structure of primary lung tumors, screen the sensitivity of therapeutic drugs, formulate lung cancer treatment programs, and realize individualized tumor treatment of lung cancer. Patients were highly matched to their PDO responses, with 84.43% accuracy, 78.01% sensitivity and 91.97% specificity.
- Conditions
- Lung Cancer, Organoid
- Being tested
- Antitumor therapy guided by organoid drug sensitivity test
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antitumor therapy guided by organoid drug sensitivity testDrug
Antitumor therapy guided by organoid will be given to Multi-line Drug-resistant Non-small Cell Lung Cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Organoid-Guided Antitumor therapy | Experimental | lung cancer specimens are obtained from lung tumor surgery or biopsy or malignant pleural effusion are used to grow organoids. Then organoids are used for drug sensitivity tests to obtain the sensitivity to drugs. Patients will receive a relatively sensitive antitumor regimen based on the test results. Receives: Drug: Antitumor therapy guided by organoid drug sensitivity test |
| Physician-decided Antitumor therapy | No intervention | According to the National Comprehensive Cancer Network's (NCCN) Guidelines for lung Cancer, physicians will determine antitumor protocols or case report. They're also not sure what the drug susceptibility test says. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from randomization to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. Lesion will be assessed in comparison to baseline measurements.
Measured: 1 year
Secondary outcomes (5)
Overall survival
Randomize time to date of death or last known alive date calculation.
Measured: 72 weeks
Disease control rate
The proportion of patients with a best response grade of complete response, partial response, or stable disease that has shrunk or stabilized for a period of time.
Measured: an average of 1 year
Changes in tumor volume shrinking
Change in tumor volume reduction from randomization to 6 months
Measured: 6 months
Prediction of the response to treatment by the patient-derived organoids
The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.
Measured: 2 years
The rate of successful generation of lung cancer organoids
Successful generation of lung cancer organoids (growth of lung tumoral cells).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start1 Feb 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- quan liu, doctor, Principal investigator, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669586
- Sponsor's protocol ID
- 136286
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Clinical Trial of Patient-derived Lung Cancer Organoids for Predicting Therapeutic Response in Patients With Multiline Drug-resistant Lung Cancer
- ClinicalTrials.gov ID
- NCT05669586
- Acronym / sponsor ID
- 136286
- Conditions
- Lung Cancer, Organoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Jan 2023 (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 is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment regiments for patients with lung cancer who are resistant to multi-line standard therapies.
Detailed description
As for the difficult problem of drug resistance in lung cancer after multi-line therapy, there is no standard consensus in clinical diagnosis and treatment, and relevant treatment plans are still being explored and the efficacy is unknown. Patient-derived organoid cells (PDOs) have become a reliable tumor model for drugs in vitro. PDOs is a personalized tumor model with similar characteristics to the original tumor. This model can maintain the molecular and cellular composition of the original tumor, reflect the heterogeneity of the original tumor, and realize in vitro high-throughput rapid screening of drug sensitivity, accurately predict the drug response of patients, so as to provide rapid clinical drug feedback. In recent years, lung cancer organoids have also been rapidly established to reproduce the tissue structure of primary lung tumors, screen the sensitivity of therapeutic drugs, formulate lung cancer treatment programs, and realize individualized tumor treatment of lung cancer. Patients were highly matched to their PDO responses, with 84.43% accuracy, 78.01% sensitivity and 91.97% specificity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organoid-Guided Antitumor therapy | Experimental | Drug: Antitumor therapy guided by organoid drug sensitivity testlung cancer specimens are obtained from lung tumor surgery or biopsy or malignant pleural effusion are used to grow organoids. Then organoids are used for drug sensitivity tests to obtain the sensitivity to drugs. Patients will receive a relatively sensitive antitumor regimen based on the test results. |
| Physician-decided Antitumor therapy | No intervention | –According to the National Comprehensive Cancer Network's (NCCN) Guidelines for lung Cancer, physicians will determine antitumor protocols or case report. They're also not sure what the drug susceptibility test says. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients: ≥18 years old.
- For non-small cell lung cancer confirmed by histology or cytology, there is no standard protocol recommendation in the guidelines for disease progression after multiline standard therapy.
- Expected survival ≥3 months.
- Sign informed consent.
- The patient is willing and able to adhere to the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
Key exclusion criteria (10 listed)
- Participated in clinical trials of other drugs within four weeks.
- Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
- Not accessible to biopsy and/or surgery sample.
- Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
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 |
|---|---|---|
| Antitumor therapy guided by organoid drug sensitivity testAntitumor therapy guided by organoid will be given to Multi-line Drug-resistant Non-small Cell Lung Cancer patients. | Drug | Organoid-Guided Antitumor therapy |
Primary outcome
Progression-free survival
Time frame: 1 year
Time from randomization to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. Lesion will be assessed in comparison to baseline measurements.
5 secondary outcomes
Overall survival
Time frame: 72 weeks
Disease control rate
Time frame: an average of 1 year
Changes in tumor volume shrinking
Time frame: 6 months
Prediction of the response to treatment by the patient-derived organoids
Time frame: 2 years
The rate of successful generation of lung cancer organoids
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
quan liu, doctor principal investigator
Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antitumor therapy guided by organoid drug sensitivity test in people with Lung Cancer and Organoid, run by Affiliated Hospital of Jiangnan University 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 7 inclusion and 10 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 19 Mar 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 quan liu, doctor (15995299079, quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). 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 19 Mar 2024.