Anlotinib in Treatment of Recurrent Small Cell Lung Cancer

One-arm, Phase II, Single-center Clinical Study of Anlotinib in the Treatment of Recurrent Small Cell Lung Cancer

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

Study Overview

• Status: Unknown
• Conditions: Recurrent Small Cell Lung Cancer
• Intervention / Treatment: Drug: Anlotinib

Detailed Description

This is an one-arm, phase II, single-center clinical study of Anlotinib in the treatment of recurrent small cell lung cancer, the objection is to exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer.It is going to enroll 43 patients.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Histological or cytologically confirmed small cell lung cancer;
3. Systemic chemotherapy that has previously received at least two or more lines regimen, followed by disease progression or recurrence;
4. According to the RECIST 1.1 standard, there is at least one measurable target lesion;
5. ECOG physical score 0-1 points; expected survival time ≥ 3 months;

6. The main organ function meets the following criteria:

   1. blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;
   2. 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;
7. Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.

Exclusion Criteria:

1. Subjects who have previously used Anlotinib;
2. 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;
3. 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;
4. 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;
5. A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
6. 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;
7. Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
8. 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;
9. Surgery (<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;
10. Active or uncontrolled serious infections;
11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
12. Increasing the risk associated with participating in a study or study drug, and at the discretion of the investigator, may lead to other conditions in which the patient is not eligible for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anlotinib; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS (Overall survival)	From the date Into this study (signed ICF) to death for any reason.	From the date Into this study (signed ICF) to death for any reason, up to 18months.
DCR (Disease control rate)	The rate of CR, PR plus SD	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)	The rate of CR and PR	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.

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (ACTUAL): November 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Recurrence; Small Cell Lung Carcinoma
• Other Study ID Numbers: ALTN-SCLC-BCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No