Non-Small Cell Lung CancerNCT05218759
Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC
A study testing Anlotinib in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.
Trial summary
Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2022to 31 Oct 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed informed consent.
- Male or female, age between 18-75 years old.
- Patients with advanced lung adenocarcinoma who failed standard treatment.
- Complete prognostic assessment information.
- Efficacy evaluation: PR/SD/PD.
- Anlotinib single drug administration.
Show all 10Show fewer
- ECOG PS score: 0-1.
- Patient's expected survival time is greater than 12 weeks.
- The functions of main organs meets the following criteria: 1) absolute neutrophil count (ANC) ≥1.5×10^9/L; 2) white blood cell count (WBC) ≥3.0×10^9/L; 3) platelet (PLT) ≥100×10^9/L; 4) hemoglobin (Hb) ≥90g/L; 5); creatinine clearance ≥50ml/min or serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); 6)serum total bilirubin (TBIL) ≤1.5×ULN; 7) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; 8) left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%); 9) Serum Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 10) ALT and AST ≤ 5ULN; 11) activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN.
- Women of childbearing age should make sure their pregnancy test is negative within 2 weeks before the study, and keep using contraceptive methods during the study and within 24 weeks after the last administration of Anlotinib. For men, they must agree to use contraceptive methods during the study period and also 24 weeks after the last administration of Anlotinib.
Who cannot join
- Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
- Patients who have used Anlotinib before.
- Pathological diagnosis results do not meet the requirements for entry.
- Patients never used TKIs.
- Patients with hemoptysis, more than 50mL per day.
- Patients with other kinds of malignancies within 5 years.
Show all 13Show fewer
- Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.
- Patients who have symptoms of diseases that affect the patient's medication.
- Patients who have suffered non-relieving toxicity from previous treatment.
- Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.
- Patients who have suffered arterial/venous thrombosis within 24 weeks.
- Patients who have been diagnosed with mental disorder.
- Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.
Trial locations and contacts
No sites are listed yet.
About this study
Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC
Read the detailed description
Explore blood exosomal miRNA as a biomarker for predicting the efficacy or risk of serious adverse reactions in patients with advanced lung adenocarcinoma (or lung squamous cell carcinoma) after anlotinib treatment.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Anlotinib
- Keywords
- Anlotinib, Non-Small Cell Lung Cancer, exosome, detection biomarker
- 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.
AnlotinibDrug
Also called H20180004
anlotinib administration at a dose of 10 mg daily
| Study group | Role | What they receive |
|---|---|---|
| arm A | Experimental | Progressive disease (PD) after anlotinib administration Receives: Drug: Anlotinib |
| arm B | Experimental | Stable disease (SD) after anlotinib administration Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD
Progressive disease (PD) after anlotinib administration
Measured: at the time of 2 months (2 cycles after treatment)
SD
Stable disease (SD) after anlotinib administration
Measured: at the time of 2 months (2 cycles after treatment)
Secondary outcomes (2)
Severe adverse reaction group
Severe adverse reaction group after anlotinib administration
Measured: at the time of 2 months (2 cycles after treatment)
Adverse reaction non-serious group
Adverse reaction non-serious group after anlotinib administration
Measured: at the time of 2 months (2 cycles after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start21 Feb 2022 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 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 Shanghai Chest 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 3D Medicines
- Responsible party
- Principal investigator, Aiqin Gu, Shanghai Chest Hospital
- Investigators
- Aiqin Gu, Chief physician, Principal investigator, Shanghai Chest Hospital, Shanghai, China, 200030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218759
- Sponsor's protocol ID
- KS(Y)21217
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2022
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT05218759
- Acronym / sponsor ID
- KS(Y)21217
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Anlotinib, Non-Small Cell Lung Cancer, exosome, detection biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- 3D Medicines
- Study start
- 21 Feb 2022 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 1 Feb 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.
Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC
Detailed description
Explore blood exosomal miRNA as a biomarker for predicting the efficacy or risk of serious adverse reactions in patients with advanced lung adenocarcinoma (or lung squamous cell carcinoma) after anlotinib treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm A | Experimental | Drug: AnlotinibProgressive disease (PD) after anlotinib administration |
| arm B | Experimental | Drug: AnlotinibStable disease (SD) after anlotinib administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who have signed informed consent.
- Male or female, age between 18-75 years old.
- Patients with advanced lung adenocarcinoma who failed standard treatment.
- Complete prognostic assessment information.
- Efficacy evaluation: PR/SD/PD.
Key exclusion criteria (13 listed)
- Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
- Patients who have used Anlotinib before.
- Pathological diagnosis results do not meet the requirements for entry.
- Patients never used TKIs.
- Patients with hemoptysis, more than 50mL per day.
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 |
|---|---|---|
| AnlotinibAlso: H20180004anlotinib administration at a dose of 10 mg daily | Drug | arm A, arm B |
Primary outcome
PD
Time frame: at the time of 2 months (2 cycles after treatment)
Progressive disease (PD) after anlotinib administration
SD
Time frame: at the time of 2 months (2 cycles after treatment)
Stable disease (SD) after anlotinib administration
2 secondary outcomes
Severe adverse reaction group
Time frame: at the time of 2 months (2 cycles after treatment)
Adverse reaction non-serious group
Time frame: at the time of 2 months (2 cycles after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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.
Aiqin Gu, Chief physician principal investigator
Shanghai Chest Hospital, Shanghai, China, 200030
Questions about this trial
What is this clinical trial studying?
A study testing Anlotinib in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.
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 10 inclusion and 13 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Aiqin Gu, MD (+86-18017321300, Guaiqin11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD (time frame: at the time of 2 months (2 cycles after treatment)). 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 1 Feb 2022.