Clinical trial · Interventional
Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
- 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)
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
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 |
|---|---|---|---|
| Extensive-stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Hydrochloride; etoposide and cisplatin | Drug | — | UNRESOLVED |
| etoposide and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anlotinib + Chemotherapy
- description
- Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).
- interventionNames
- Drug: Anlotinib Hydrochloride; etoposide and cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy
- description
- Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.
- interventionNames
- Drug: etoposide and cisplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of small cell lung caner * Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1) * Males or females between 18 Years to 75 Years. * Performance status of 0~2 on the ECOG criteria. * Main organs function is normal * Expected survival is above three months. * with asymptomatic brain metastases. * At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion \>= 20mm or spiral CT \>=10mm). * Adequate hematologic (Leukocyte count \>= 4.0×109/L, neutrophil count\>=2.0×109/L, hemoglobin\>=95g/L, platelets\>=100×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x1.5, bilirubin level =\< UNL x 1.5). * Patient can take oral medicine. * Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up. Exclusion Criteria: * History of cardiovascular disease: congestive heart failure (CHF) \> New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin). * Serious clinical infection (\> NCI-CTCAE version 4.0 ,infection standard II). * Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents). * The patients had accepted allogeneic organ transplantation. * Bleeding tendency or coagulation disorders. * patients who need renal dialysis. * suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor). * uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg). * thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months). * pulmonary hemorrhage \>CTCAE grade 2 within 4 weeks before first use of drugs. * Other organ hemorrhage \>CTCAE grade 3 within 4 weeks before first use of drugs. * severe uncured wounds, ulcers or fracture. * uncured dehydration. * Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect. * Patients are allergic to drugs used in research. * Factors influencing the safety and compliance of patients. * Inability to comply with protocol or study procedures. * Pregnant or breast-feeding. * The researcher believe that the Patient is not suitable to participate in the study.
References
Publications (0)
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