A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC

NCT03700359 | Unknown Phase 2

• 1 other identifier: ES-SCLC 001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.

Conditions

Small Cell Lung Carcinoma

Keywords

extensive-stage small-cell lung cancer; lobaplatin/etoposide; Anlotinib maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Time

  Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.

  Time from randomization to first documented progression, assessed for up to 2 years

Secondary Outcomes (2)

• Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)

  Up to 2 years

• Overall Survival

  Time from randomization to death by any cause, assessed for up to 3 years

Other Outcomes (1)

• Percentage of Participants Experiencing an Adverse Event (AE)

  Up to 2 years

Study Arms (2)

Anlotinib/Lobaplatin/Etoposide

EXPERIMENTAL

EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy

Drug: Anlotinib Hydrochloride; Drug: Lobaplatin; Drug: Etoposide

Lobaplatin/Etoposide

ACTIVE COMPARATOR

EL regimen for 4 cycles

Drug: Lobaplatin; Drug: Etoposide

Interventions

Anlotinib Hydrochloride DRUG

Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation

Also known as: AL3818

Anlotinib/Lobaplatin/Etoposide

Lobaplatin DRUG

Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days

Also known as: D-19466

Anlotinib/Lobaplatin/Etoposide; Lobaplatin/Etoposide

Etoposide DRUG

Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days

Also known as: VP16

Anlotinib/Lobaplatin/Etoposide; Lobaplatin/Etoposide

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed patients with extensive small cell lung cancer;
• Karnofsky performance status ≥70;
• At least one lesion that can measured by CT;
• Expected to survive for at least 3 months;
• Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
• White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
• Hemoglobin (HGB) ≥80 g/L；
• Platelet (PLT) ≥100×109/L;
• Liver transaminases（AST/ALT）\<3.0 times the normal range limit;
• Total bilirubin（TBIL）\<1.5 times the normal range limit;
• Creatinine（CREAT）\<1.5 times the normal range limit;
• Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
• Signed informed consent;
• Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
• Human immunodeficiency virus (HIV);

You may not qualify if:

• Other pathological types of tumor except for small cell lung cancer;
• Patients with a history of severe allergies or allergies;
• Pregnancy or breastfeeding women;
• Patients who have previously participated in other clinical trials and have not yet terminated the trial;
• 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;
• Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib; lobaplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jiexia Zhang

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiexia Zhang, MD, PhD

CONTACT

86 20 83062830; drzjxcn@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: October 9, 2018
• Study Start: March 1, 2019
• Primary Completion: November 29, 2020
• Study Completion: November 29, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

CN (1)