Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer

Last updated: December 22, 2020
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT04684017
KS2039
  • Ages 18-75
  • All Genders

Study Summary

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of etoposide and carboplatin (administered intravenously) in combination with anlotinib (administered orally) in treatment-naive advanced NSCLC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patientswith extensive stage SCLC confirmed by histology or cytology and are confirmed to haveat least one measurable lesion according to RECIST 1.1.
  2. Without active brain metastasis
  3. Previously treated with ICIs with progressive disease.
  4. Age ≥18 years and ≤75 years;
  5. ECOG PS score: 0 to 1
  6. The main organs function is normal, that is, the following criteria met: goodhematopoietic function, defined as absolute neutrophil count ≥1.5×109 /L, plateletcount≥100 ×109 /L, hemoglobin ≥90g/L [no blood transfusion or no erythropoietin (EPO)dependence within 7 days before enrollment]; biochemical test results should meet thefollowing criteria: BIL < 1.25 times the upper limit of normal value (ULN); ALT andAST < 2.5 × ULN; in case of liver metastases, ALT and AST < 5 × ULN; Cr ≤1.5×ULN orcreatinine clearance (CCr) ≥60ml/min; Coagulation function is good, INR and PT ≤1.5times ULN; if the subject is receiving anticoagulant treatment, PT should be withinthe prescribed range of use of anticoagulant drugs;
  7. Women of child-bearing age should agree to take contraceptive measures (such asintrauterine devices, contraceptives or condoms) during the study and within 6 monthsafter the study; non-breast-feeding patients whose serum or urinary pregnancy testshould be negative; male patients should agree to take contraceptive measures duringthe study and within 6 months after the study.
  8. Patients are voluntarily enrolled into the study, sign the informed consent form andhave good compliance.

Exclusion

Exclusion Criteria:

  1. Subjects with active CNS metastases are excluded.
  2. Non-small cell lung cancer.
  3. With obvious hemorrhage symptom
  4. Patients with many factors affecting oral medication, such as dysphagia,gastrointestinal resection, chronic diarrhea and intestinal obstruction.
  5. Combined with other tumors at the time of initial diagnosis.
  6. Patients who have previously participated in other clinical trials and have not yetterminated the trial.
  7. Patients who have acute infection that difficult to control.

Study Design

Total Participants: 29
Study Start date:
May 01, 2019
Estimated Completion Date:
January 01, 2022

Study Description

Lung cancer can be divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), of which SCLC accounts for about 15%-20%.Because of the high degree of malignancy of SCLC, patients often lose the opportunity of surgical treatment due to metastasis at the time of admission. Traditional cytotoxic drugs can improve the prognosis of patients and life treatment, but the survival benefit is very limited.

Vascular targeted therapy is an important treatment strategy for metastatic lung cancer.Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3). An exploratory phase II study explored the efficacy of third-line single-drug therapy for ED-SCLC and found significant improvement in prognosis.

Based on the above status and research results, the purpose of this study was to explore the efficacy and safety of anlotinib hydrochloride combined with etoposide/carboplatin in first-line treatment of extensive small-cell lung cancer.

Connect with a study center

  • Shanghai Chest hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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