Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

NCT03781869 | Unknown Phase 2 DMC

• 1 other identifier: ALT-SCLC-01
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Extensive-stage Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Anlotinib; Maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The first day of treatment to the date that disease progression is reported

  From randomization，each 42 days up to PD or death(up to 24 months

Secondary Outcomes (5)

• Overall survival

  From randomization until death (up to 5 years)

• Objective Response Rate

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Treatment-related adverse events

  the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months

• Performance Status

  the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months

• Disease Control Rate

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (2)

Anlotinib + Chemotherapy

EXPERIMENTAL

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).

Drug: Anlotinib Hydrochloride; etoposide and cisplatin

Chemotherapy

PLACEBO COMPARATOR

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.

Drug: etoposide and cisplatin

Interventions

Anlotinib Hydrochloride; etoposide and cisplatin DRUG

etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days

Anlotinib + Chemotherapy

etoposide and cisplatin DRUG

etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days

Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Etoposide; Cisplatin

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Dong Wang, PH.D

  Daping Hospital, Third Military Medical University, Chongqing,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, PH.D.

CONTACT

86-23-68757151; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 20, 2018

Record last verified: 2018-12