Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride

Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride in in Combination With EC/EP

This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Anlotinib Hydrochloride

Detailed Description

Lung cancer is a common malignant tumor that poses a serious threat to human health. Small cell lung cancer accounts for about 20% of lung cancer. Precision medicine has recently been perfectly interpreted in many tumor types, but the treatment of small cell lung cancer is still bleak. The EC/EP regimen is the most classic chemotherapy regimen for small cell lung cancer with good results but is prone to drug resistance. In 2018, with the development of immunotargeting therapy, small molecule multi-target anti-angi drugs, PARP inhibitors, new chemotherapy drugs, etc., the treatment of small cell lung cancer has ushered in a new dawn. As a kind of highly selective multi-target anti-angiogenic TKI drugs,Anlotinib Hydrochloride is a kind of 1.1 innovative drugs with independent intellectual property rights in China, mainly acting on VEGFR, PDGFR, FGFR and c-Kit. The latest ALTER1202 study confirms that anlotinib is significantly improved for PSC and ORR in SCLC patients who have previously received at least 2-line chemotherapy. OS data is not yet mature, but the benefits of the anlotinib group were observed. The adverse effects of anlotinib were consistent with expectations, no new adverse events were found, and safety was tolerated. Nowadays, the effective combination of traditional chemical therapy with molecular targeting and immunotherapy is the future development direction of lung cancer treatment. Therefore, this topic is designed to combine the efficacy of safety and safety with the treatment of anlotinib with the classic EC/EP chemotherapy regimen. Expected to get longer PFS and OS for patient benefit.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongbo JI, postgraduate; Phone Number: 18604868579; Email: docjihongbo@qq.com
• Study Contact Backup: Name: Lele Wang, Bachelor; Phone Number: 18604868579; Email: 15754816534@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patients 18-75 years of age.
2. A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
3. a measurable disease
4. an Eastern Cooperative Oncology Group PS of 0-1;
5. an estimated survival duration of >6 months;

Exclusion Criteria:

1. Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)2. Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical trial group; （Carboplatin/cisplatin + etoposide）+ （Anlotinib Hydrochloride 12 mg/day ，Each cycle was defined as 2 weeks on-treatment fol- lowed by 1 week off-treatment）, after 4-6 cycles of treatment, the treatment was continued with anlotinib until disease progression.	Drug: Anlotinib Hydrochloride; Best supportive care; Other Names: Focusv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	nine months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR	disease control rate	12 months
OS	overall survival	12 months
ORR	Objective Response Rate	12 months
safety assessed by Adverse reactions	Adverse reactions	12 months

Collaborators and Investigators

• Sponsor: Chifeng Municipal Hospital

Publications and helpful links

General Publications

• Han JY, Kim HY, Lim KY, Han JH, Lee YJ, Kwak MH, Kim HJ, Yun T, Kim HT, Lee JS. A phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. Lung Cancer. 2013 Feb;79(2):137-42. doi: 10.1016/j.lungcan.2012.09.019. Epub 2012 Nov 20.

Helpful Links

• National Institutes of Heaith

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: B19267BT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No