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Anlotinib Combined With Etoposide and Platinum in the Treatment of Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

Phase II Clinical Trial of Anlotinib Combined With Etoposide and Platinum in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT03841136•Fudan University

View on ClinicalTrials.gov

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 survival (OS), objective response rate (ORR), disease control rate (DCR), and quality of life (QoL) of patients with extensive stage small cell lung cancer treated with anlotinib

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients volunteered to participate in the study and have signed the informed consent.
•2. Histological or cytological diagnosis of extensive small cell lung cancer, and no indication of radical surgery or radiotherapy.
•3. 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.
•4. 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:
•1. 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
•2. 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;
•3. 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.
+1 more criteria

Exclusion Criteria

•1. Patients who have been treated with anlotinib capsules in the past.
•2. Patients who have previously received systemic chemotherapy, signal transduction inhibitors, targeted therapies, hormone and endocrine therapy.
•3. 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.
•4. Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or higher, excluding hair loss.
•5. Patients with a variety of factors affecting oral medications (such as dyspahgia, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
•6. Patients with symptomatic CNS metastases.
•7. 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.
•8. Patients with major surgical treatment, incisional biopsy or tremendous traumatic injury within 28 days prior to the enrollment.
•9. 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.
•10. Patients with uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage.
+14 more criteria

Locations (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 1, 2019

Primary Completion Date

December 1, 2019

Completion Date

December 31, 2021

Last Updated

March 28, 2019

Enrollment

ESTIMATED participants

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

anlotinib

DRUG

Contacts

wang jia lei, doctor

CONTACT

18017312369 haitunqiao@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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