Clinical Study of Anlotinib in Maintenance Treatment of Advanced NSCLC

NCT03769805 | Unknown

• 1 other identifier: ALTER-L014
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the need of clinical practice of maintenance therapy for advanced NSCLC and the reliable data of third-line treatment for non-small cell lung cancer, the investigators designed a clinical study of antinil hydrochloride versus pemetrexed in maintenance therapy for advanced NSCLC to prospectively evaluate the efficacy of antinil hydrochloride in maintenance therapy for advanced NSCLC. Value, to provide a scientific basis for prolonging the survival time of patients with advanced NSCLC, improving the quality of life of patients in the course of treatment, and optimizing treatment strategies to a greater extent.

Conditions

Nonsmall Cell Lung Cancer

Keywords

anlotinib; Maintenance treatment

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  5 month

Secondary Outcomes (1)

• OS

  through study completion, an average of 18 month

Study Arms (1)

Anlotinib Arm

EXPERIMENTAL

Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week. Patients with complete remission (CR), partial remission (PR) and stable disease (SD) continued to administer drugs until the disease progressed, intolerable toxicity or withdrawal was required. Patients with progression of illness (PD) discontinued their medication.

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week.

Anlotinib Arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC was diagnosed by cytology or histology, and patients with stage IIIB or IV and no sensitive mutation of EGFR/ALK/ROS1 were diagnosed according to IASLC Staging Standard (IASLC 2007 9) of the 7th edition of 2009;
• Those who had received platinum-containing two-drug combination chemotherapy for 4-6 cycles were judged as complete remission (CR), partial remission (PR) and stabilization (SD) according to RECIST 1.1 standard; (Specific schemes of platinum-containing two-drug combination chemotherapy included vinorelbine+cisplatin/carboplatin, gemcitabine+cisplatin/carboplatin, paclitaxel+cisplatin/carboplatin, albumin. Binding paclitaxel + cisplatin / carboplatin, docetaxel + cisplatin / carboplatin, pemetrexed + cisplatin / carboplatin, and squamous cell carcinoma may include docetaxel + nedaplatin)
• Age: 18 to 74 years old, regardless of gender;
• PS 0～1(ECOG) ;
• The life expectancy is more than 3 months;
• According to RECIST 1.1 criteria, patients have at least one imaging (CT, MRI) lesion that can be measured or evaluated; the lesion was not previously treated by radiotherapy. The longest diameter of the target lesion should be greater than or equal to 10 mm (the short axis of lymph node is greater than or equal to 15 mm);
• Patients with brain metastasis at baseline should be single intracranial metastasis, asymptomatic or asymptomatic after treatment;
• Women: For all women who may be pregnant, pregnancy tests must be performed within 72 hours before starting treatment, or medically approved contraceptive methods must be used within three months after the treatment and during the period after the end of treatment; serum or urine pregnancy tests must be negative and must be non-lactating; Male: Contraceptive measures were taken during and within 3 months after surgical sterilization or treatment;
• The functional level of organs must meet the following requirements:
• Routine blood test ANC is more than 1.5 x 109/L; PLT is more than 90 x 109/L; Hb \> 90g/L Blood biochemistry TBIL is less than 1.5 x ULN ALT and AST \< 2 \*ULN; for patients with liver metastases, ALT and AST \< 5 \*ULN; BUN and CR were less than 1.5 x ULN and creatinine clearance was more than 50 ml/min.
• Colour Sonography LVEF is more than 50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was \< 450 ms for males and \< 470 MS for females.
• Subjects who have the ability to understand and sign the informed consent must sign the informed consent before any screening evaluation.

You may not qualify if:

• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
• There is a third interstitial effusion (e.g. massive pleural and ascites) that cannot be controlled by drainage or other means;
• Radiotherapy, surgical treatment, or other targeted therapy for non-small cell lung cancer was given within four weeks before the first study drug was administered;
• Researchers judged that they had not recovered from previous adverse events before taking the drug for the first time (NCI-CTCAE Version 4.0 Grade \> Grade 1);
• Patients with multiple or active (uncontrolled) brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with single brain metastases whose symptoms were stable and had completed treatment within 28 days prior to the first use of the research drug) may be enrolled in the group, but only through craniocerebral MRI, CT or venography. Shadow evaluation confirmed no symptoms of cerebral hemorrhage;
• Participated in other drug clinical trials within 4 weeks before taking the first research drug;
• There was a history of bleeding. Within 4 weeks before screening, any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred;
• Having a history of thrombosis, or judging by researchers, abnormal coagulation function has clinical significance, tends to bleed, or is undergoing thrombolysis or anticoagulation therapy;
• Hemoptysis was evident within 2 months before the first study drug was administered;
• Patients with hypertension who could not be well controlled by a single antihypertensive drug (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg); patients with a history of unstable angina pectoris; newly diagnosed angina pectoris in the first three months of screening or myocardial infarction events in the first six months of screening; arrhythmia (including QTcF: males \> 450 ms, females) Long-term use of antiarrhythmic drugs and New York Heart Association Classification (\> Class II) cardiac insufficiency were required;
• Urinary routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification \> 1.0 G;
• Long-term union of wounds or incomplete healing of fractures;
• Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
• Those with allergic constitution or known history of allergy to the drug components of this regimen;
• Has a history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Huai'an First People's Hospital: collaborator
• Jiangsu Taizhou People's Hospital: collaborator
• Zhongda Hospital: collaborator
• Yancheng City NO.1 People's Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jangsu, China

RECRUITING

Related Publications (1)

• Liu Y, Miao L, Chen X, Zhu X, Li Y, He J, Chen P, Dai S, Liu Z, Ma K, Wang N, Zhao Y, Chen N, Song W, Bai R, Cui J, Shu Y. Maintenance therapy with anlotinib after induction therapy with platinum-based chemotherapy for advanced non-small-cell lung cancer: A pooled analysis of 2 single-arm trials. Medicine (Baltimore). 2024 Jul 5;103(27):e38459. doi: 10.1097/MD.0000000000038459.

  PMID: 38968520 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongqian Shu, professor

  JANGSU PROVINCE HOSPITAL

  STUDY CHAIR

Central Study Contacts

Yongqian Shu, PhD

CONTACT

00862568306428; shuyongqian@csco.org.cn

Yiqian Liu, PhD

CONTACT

008613813804568

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 10, 2018
• Study Start: June 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

CN (1)