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

NCT ID: NCT04684017

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-01-01

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.

Conditions

SCLC; Anlotinib

Keywords

SCLC; Anlotinib

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib plus etoposide and carboplatin

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

Group Type: EXPERIMENTAL

Anlotinib hydrochloride

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Anlotinib hydrochloride

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

Intervention Type: DRUG

Etoposide

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

anlotinib; VP-16

Eligibility Criteria

Inclusion Criteria

1. 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.

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: 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;

7. 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.

8. Patients are voluntarily enrolled into the study, sign the informed consent form and have good compliance.

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 yet terminated the trial.

7. Patients who have acute infection that difficult to control.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Baohui Han

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baohui Han

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Baohui Han

Role: CONTACT

Phone: +86 18930858216

Email: 18930858216@163.com

Facility Contacts

Baohui Han

Role: primary

References

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.

Reference Type: DERIVED

PMID: 36116169 (View on PubMed)

Other Identifiers

KS2039

Identifier Type: -

Identifier Source: org_study_id