Back to results

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

Primary Purpose

SCLC, Anlotinib

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib hydrochloride

Etoposide

Carboplatin

About this trial

This is an interventional treatment trial for SCLC focused on measuring SCLC, Anlotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shanghai Chest hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib plus etoposide and carboplatin

Arm Description

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

Outcomes

Primary Outcome Measures

PFS

Time from enrollment to progression or death

Secondary Outcome Measures

ORR

Patients who were assessed as partial response or complete response

Time from enrollment to death of any cause

DCR

Patients who were assessed as partial response, complete response or stable disease

Full Information

NCT ID

NCT04684017

First Posted

December 22, 2020

Last Updated

December 22, 2020

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04684017

Brief Title

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

Official Title

Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer: A Single Arm Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SCLC, Anlotinib

Keywords

SCLC, Anlotinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anlotinib plus etoposide and carboplatin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib hydrochloride

Other Intervention Name(s)

anlotinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

PFS

Description

Time from enrollment to progression or death

Time Frame

Time from randomization to progression, assessed 9-11 months

Secondary Outcome Measure Information:

Title

ORR

Description

Patients who were assessed as partial response or complete response

Time Frame

6-9 weeks

Title

Description

Time from enrollment to death of any cause

Time Frame

13-15 months

Title

DCR

Description

Patients who were assessed as partial response, complete response or stable disease

Time Frame

6-9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Baohui Han

Phone

+86 18930858216

18930858216@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baohui Han

Organizational Affiliation

Shanghai Chest Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Chest hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baohui Han

Phone

8618930858216

Ext

8618930858216

18930858216@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

36116169

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs