Anlotinib in Treatment of Recurrent Small Cell Lung Cancer

NCT03732846 | Unknown Phase 2

• 1 other identifier: ALTN-SCLC-BCH
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer

Conditions

Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS (Progression-Free survival)

  From the date Into this study (signed ICF) to tumor progression or death for any reason.

  From the date Into this study (signed ICF) to tumor progression or death for any reason, up to 18 months.

Secondary Outcomes (3)

• OS (Overall survival)

  From the date Into this study (signed ICF) to death for any reason, up to 18months.

• DCR (Disease control rate)

  From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.

• ORR (Objective control rate)

  From the beginning of treatment, CT and ultrasound examinations are performed every six weeks to assess changes in the disease until the disease progression or death, up to 18 months.

Study Arms (1)

Anlotinib

EXPERIMENTAL

Take Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression.

Drug: Anlotinib

Interventions

Anlotinib DRUG

Take Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression

Anlotinib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old;
• Histological or cytologically confirmed small cell lung cancer;
• Systemic chemotherapy that has previously received at least two or more lines regimen, followed by disease progression or recurrence;
• According to the RECIST 1.1 standard, there is at least one measurable target lesion;
• ECOG physical score 0-1 points; expected survival time ≥ 3 months;
• The main organ function meets the following criteria:
• blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;
• Blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
• Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.

You may not qualify if:

• Subjects who have previously used Anlotinib;
• Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
• Imaging (CT or MRI) shows central tumors in which tumor lesions invade local large blood vessels; imaging (CT or MRI) shows significant pulmonary cavitary or necrotizing tumors; or other factors identified by the investigator that may cause hemoptysis disease;
• A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
• A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
• Cardiac diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia with difficult drug control (including clinically significant QTc interval prolongation history, or screening period QTc interval women \>470ms, Male \> 450ms), had myocardial infarction within 6 months, or cardiac insufficiency;
• Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
• Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
• Surgery (\<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;
• Active or uncontrolled serious infections;
• Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jian Fang

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Di Wu

CONTACT

010-88196478; lucia8810@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 7, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

CN (1)