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

• Status: Recruiting
• Trial end date: 2021-11-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Etoposide; Etoposide phosphate

Criteria

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.