Anlotinib Combined With Etoposide and Platinum in the Treatment of Lung Cancer

NCT03841136 | Unknown Phase 2

• 1 other identifier: ALTN-SCLC-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Extensive-stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen

  from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (1)

anlotinib combined with EP

EXPERIMENTAL

anlotinib combined with etoposide and platinum

Drug: anlotinib

Interventions

anlotinib DRUG

anlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1\~D3

Also known as: etoposide and platinum

anlotinib combined with EP

Eligibility Criteria

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

You may qualify if:

• 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.
• ）18\~75 years old; ECOG PS score: 0\~1 points; expected survival time is more than 3 months.
• ）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%).
• ）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.
• ）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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib; Etoposide; Platinum

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; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

wang jia lei, doctor

CONTACT

18017312369; haitunqiao@hotmail.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: Attending

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 15, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2021
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

CN (1)