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

Small Cell Lung Carcinoma Clinical Trial

Official title:

A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700359
• Other study ID #: ES-SCLC 001
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: November 29, 2021

Study information

• Verified date: November 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jiexia Zhang, MD, PhD
• Phone: 86 20 83062830
• Email: drzjxcn[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.

SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.

This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histopathologically confirmed patients with extensive small cell lung cancer;

2. Karnofsky performance status =70;

3. At least one lesion that can measured by CT;

4. Expected to survive for at least 3 months;

5. 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;

6. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;

7. Signed informed consent;

8. 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.

9. Human immunodeficiency virus (HIV);

10. Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.

Exclusion Criteria:

1. Other pathological types of tumor except for small cell lung cancer;

2. Patients with a history of severe allergies or allergies;

3. Pregnancy or breastfeeding women;

4. Patients who have previously participated in other clinical trials and have not yet terminated the trial;

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;

8. Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Drug:
• Anlotinib Hydrochloride
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
• Lobaplatin
Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
• Etoposide
Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Experiencing an Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure	Up to 2 years
Primary	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	Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)	Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.	Up to 2 years
Secondary	Overall Survival	Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.	Time from randomization to death by any cause, assessed for up to 3 years