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

• Sponsor: Shanghai Chest Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05218759
• Collaborator: 3D Medicines (Industry)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 44.3

Study Details

Study Description

Brief Summary

Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: Anlotinib	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC
• Anticipated Study Start Date: Feb 21, 2022
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: arm A Progressive disease (PD) after anlotinib administration	Drug: Anlotinib; anlotinib administration at a dose of 10 mg daily; Other Names: H20180004
Experimental: arm B Stable disease (SD) after anlotinib administration	Drug: Anlotinib; anlotinib administration at a dose of 10 mg daily; Other Names: H20180004

Outcome Measures

Primary Outcome Measures

1. PD [at the time of 2 months (2 cycles after treatment)]

   Progressive disease (PD) after anlotinib administration

2. SD [at the time of 2 months (2 cycles after treatment)]

   Stable disease (SD) after anlotinib administration

Secondary Outcome Measures

1. Severe adverse reaction group [at the time of 2 months (2 cycles after treatment)]

   Severe adverse reaction group after anlotinib administration

2. Adverse reaction non-serious group [at the time of 2 months (2 cycles after treatment)]

   Adverse reaction non-serious group after anlotinib administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

11. Patients who have suffered arterial/venous thrombosis within 24 weeks.

12. Patients who have been diagnosed with mental disorder.

13. Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Chest Hospital
• 3D Medicines

Investigators

• Principal Investigator: Aiqin Gu, Chief physician, Shanghai Chest Hospital, Shanghai, China, 200030

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aiqin Gu, Chief physician, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT05218759
• Other Study ID Numbers: KS(Y)21217
• First Posted: Feb 1, 2022
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aiqin Gu, Chief physician, Shanghai Chest Hospital: Anlotinib; Non-Small Cell Lung Cancer; exosome; detection biomarker
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 1, 2022