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

NCT04684017 | Unknown Phase 2

• 1 other identifier: KS2039
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCLC; Anlotinib

Keywords

SCLC; Anlotinib

Outcome Measures

Primary Outcomes (1)

• PFS

  Time from enrollment to progression or death

  Time from randomization to progression, assessed 9-11 months

Secondary Outcomes (3)

• ORR

  6-9 weeks

• OS

  13-15 months

• DCR

  6-9 weeks

Study Arms (1)

Anlotinib plus etoposide and carboplatin

EXPERIMENTAL

Etoposide and carboplatin plus anlotinib for 4 cycles and anlotinib as maintenance therapy

Drug: Anlotinib hydrochloride; Drug: Etoposide; Drug: Carboplatin

Interventions

Anlotinib hydrochloride DRUG

anlotinib 10 mg/day orally (from days 1 to 14 in a 21-day cycle)

Also known as: anlotinib

Anlotinib plus etoposide and carboplatin

Etoposide DRUG

100mg/m2 iv on days 1-3 every 21 days for 4 cycles

Also known as: VP-16

Anlotinib plus etoposide and carboplatin

Carboplatin DRUG

AUC 5 iv on day 1 every 21 days for 4 cycles

Anlotinib plus etoposide and carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• Zhang W, Deng P, Kong T, Zhang B, Qian F, Dong Y, Chen Y, Chen L, Liu D, Zhang Y, Yang H, Han B. Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2). Lung Cancer. 2022 Nov;173:43-48. doi: 10.1016/j.lungcan.2022.09.003. Epub 2022 Sep 8.

  PMID: 36116169 DERIVED

MeSH Terms

Interventions

anlotinib; Etoposide; Carboplatin

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Baohui Han

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Baohui Han

CONTACT

+86 18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 24, 2020
• Study Start: May 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 24, 2020

Record last verified: 2019-12

Locations

CN (1)