Clinical trial NCT03732846: Anlotinib in Treatment of Recurrent Small Cell Lung Cancer
Official title: One-arm, Phase II, Single-center Clinical Study of Anlotinib in the Treatment of Recurrent Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Small Cell Lung Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS (Progression-Free survival)
timeFrame: From the date Into this study (signed ICF) to tumor progression or death for any reason, up to 18 months.
Secondary outcomes:
measure: OS (Overall survival)
timeFrame: From the date Into this study (signed ICF) to death for any reason, up to 18months.
measure: DCR (Disease control rate)
timeFrame: 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.
measure: ORR (Objective control rate)
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jian Fang
role: PRINCIPAL_INVESTIGATOR
References: