Status:
UNKNOWN
Anlotinib Combined With Etoposide and Platinum in the Treatment of Lung Cancer
Lead Sponsor:
Fudan University
Conditions:
Extensive-stage Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
Detailed Description
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen To evaluate the safety, tolerability, overall survi...
Eligibility Criteria
Inclusion
- Patients volunteered to participate in the study and have signed the informed consent.
- Histological or cytological diagnosis of extensive small cell lung cancer, and no indication of radical surgery or radiotherapy.
- There are measurable lesions defined by RECIST standard v1.1. A lesion can be considered measurable only if the previously irradiated lesion has clear progression after radiotherapy and the previous irradiated lesion is not the sole lesion.
- Initially treated patients who have not received any systematic therapy before. If have received postoperative adjuvant chemotherapy, the time to relapse is at least 6 months from the last adjuvant chemotherapy.
- 5）18\~75 years old; ECOG PS score: 0\~1 points; expected survival time is more than 3 months.
- 6）The main organs's function meets the following criteria within 14 days before treatment:
- Routine blood test (without blood transfusion within 14 days): a) Hemoglobin (HB) ≥ 90 g / L; b) Absolute neutrophil (ANC) ≥ 1.5 × 109 / L; c) Platelets (PLT) ≥ 80×109/L
- Biochemical examination: a) Total bilirubin (TBIL) ≤ 1.5 times of the upper limit of the normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN.To patients with liver metastasis, ALT and AST ≤ 5ULN; c) Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%).
- 7）Patients with previously treated asymptomatic CNS metastases are allowed to participate in this study if all of the following criteria are met: a) No need for continuous corticosteroid therapy for CNS disease; b) No radiotherapy within 7 days prior to enrollment treatment; c) Imaging examination from the end of radiotherapy to screening period shows no CNS progression.
- 8）Women of childbearing age should agree to conduct contraception (such as intrauterine devices, contraceptives or condoms) during the study and within 6 months after the end of the study; and the serum or urine pregnancy test is negative within 7 days prior to study enrollment and they must be non-lactating patients; Men should agree to conduct contraception during the study and within 6 months after the end of the study.
Exclusion
- Patients who have been treated with anlotinib capsules in the past.
- Patients who have previously received systemic chemotherapy, signal transduction inhibitors, targeted therapies, hormone and endocrine therapy.
- Patients with other malignant tumors occurred within 5 years prior to the enrollment, except those with cured cervical carcinoma in situ and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\] , basal or squamous cell skin cancer, and localized prostate cancer and ductal breast carcinoma in situ treated with radical surgery.
- Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or higher, excluding hair loss.
- Patients with a variety of factors affecting oral medications (such as dyspahgia, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Patients with symptomatic CNS metastases.
- Patients with dysfucitonal coagulation (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), and bleeding tendency (the following condition must be met within 14 days before the enrollment: the INR is within the normal range without using anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or the like; Patients with International Normalized Ratio (INR) of less than1.5 are allowed to use low-dose warfarin (1 mg orally, once daily) or aspirin (with a daily dose of no more than 100 mg) for prophylactic purposes.
- Patients with major surgical treatment, incisional biopsy or tremendous traumatic injury within 28 days prior to the enrollment.
- Patients with tumors that have invaded tissues surrounding vital blood vessels founded in imaging or with a high probability of fatal bleeding due to the invasion of tumors to vital blood vessels according to the judgements of the researchers during the follow-up study.
- Patients with uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage.
- Patients with any severe and/or uncontrolled disease, including:
- Patients with unsatisfactory blood pressure control (systolic blood pressure \>150 mmHg, diastolic blood pressure \>90 mmHg).
- Patients with myocardial ischemia or myocardial infarction of Grade I of higher level, arrhythmia (including QTC ≥ 440ms) and congestive heart failure above Grade 2 (New York Heart Association (NYHA) classification).
- Patients with active or uncontrolled severe infection (≥ CTC AE Level 2).
- Patients with a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- Patients with poor control of diabetes (fasting blood glucose (FBG)\>10mmol/L).
- Patients with urine protein ≥ ++ indicated by routine urine test, and confirmed 24-hour urine protein quantitation \> 1.0 g.
- Patients with seizures requiring treatment.
- Patients with bleeding tendency or medical history regardless of severity; Patients undergone bleeding events of a level ≥ CTCAE 3 within 4 weeks prior to the enrollment, and with unhealed wounds, ulcers or fractures.
- Patients undergone venous thrombosis events currently or within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
- Patients with a history of psychotropic drug abuse from which they are unable to abstain or with mental disorders.
- Patients who have participated in other clinical trials of anti-tumor drugs within four weeks.
- Patients with severe disease that threaten the safety of themselves or affect the completion of the study according to the investigators' judgment.
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Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03841136
Start Date
April 1 2019
End Date
December 31 2021
Last Update
March 28 2019
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032