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Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC | Clinical Trials | Clareo Health

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Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC

NCT05218759•Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who have signed informed consent.
•2. Male or female, age between 18-75 years old.
•3. Patients with advanced lung adenocarcinoma who failed standard treatment.
•4. Complete prognostic assessment information.
•5. Efficacy evaluation: PR/SD/PD.
•6. Anlotinib single drug administration.
•7. ECOG PS score: 0-1.
•8. Patient's expected survival time is greater than 12 weeks.
•9. 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.
•10. 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.

Exclusion Criteria

•1. Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
•2. Patients who have used Anlotinib before.
•3. Pathological diagnosis results do not meet the requirements for entry.
•4. Patients never used TKIs.
•5. Patients with hemoptysis, more than 50mL per day.
•6. Patients with other kinds of malignancies within 5 years.
•7. Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.
•8. Patients who have symptoms of diseases that affect the patient's medication.
•9. Patients who have suffered non-relieving toxicity from previous treatment.
•10. Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.
+3 more criteria

Key Dates

Start Date

February 21, 2022

Primary Completion Date

May 31, 2025

Completion Date

October 31, 2025

Last Updated

February 1, 2022

Enrollment

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Anlotinib

DRUG

Contacts

Aiqin Gu, MD

CONTACT

+86-18017321300 Guaiqin11@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)