Clinical trial · Interventional
A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Hydrochloride | Drug | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| Lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anlotinib/Lobaplatin/Etoposide
- description
- EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
- interventionNames
- Drug: Anlotinib Hydrochloride
- Drug: Lobaplatin
- Drug: Etoposide
- type
- ACTIVE_COMPARATOR
- label
- Lobaplatin/Etoposide
- description
- EL regimen for 4 cycles
- interventionNames
- Drug: Lobaplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- Progression Free Survival Time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available