Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020）

An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.

Study Overview

• Status: Unknown
• Conditions: Non-squamous NSCLC
• Intervention / Treatment: Drug: Anlotinib

Detailed Description

It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.

• Study Type: Interventional
• Enrollment (Anticipated): 103
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: enxiao li, professor; Phone Number: 0086-13992819833; Email: doclienxiao@sina.com
• Study Contact Backup: Name: jingjing miao; Phone Number: 0086-18392055301; Email: miaojing0403@163.com

Study Locations

• China
  • Shanxi
    • Xian, Shanxi, China, 710000
      • Recruiting
      • Shaanxi Provincial Cancer Hospital
      • Contact: minhui wu, doctor; Phone Number: 13891825509; Email: wuminhui@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed and dated informed consent
• Age：18~75 years;
• Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC
• at least two systematic chemotherapy with upwards of 1-line treatments or cannot suffer
• The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
• Subjects with at least one measurable lesion as defined by RECIST (version 1.1)
• Expected Survival Time: Over 3 months
• ECOG PS：0-1,
• main organs function is normal
• The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it

Exclusion Criteria:

• 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
• lung squamous carcinoma
• Other active malignancies requiring treatment
• History of malignancy
• Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
• Abnormal coagulation (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN); Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
• take major surgical treatments or have serious trauma before grouping, or the impact of surgery or trauma has been eliminated for less than 14 days.
• Patients with active or unable to control serious infections;
• Patients with Grade II or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients with grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification)
• Patients with non-healing wounds or fractures
• with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus).
• get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
• plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy
• Patients with cirrhosis, decompensated liver disease, or active hepatitis Have suffered from hemorrhagic disease or coagulation dysfunction
• diagnosed with disease which will severely endanger the security of patients or influence the completion of this research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib; Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent	Drug: Anlotinib; Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.; Other Names: AL3818

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1	Progress free survival (PFS)	Baseline until PD or death, whichever occurs first (up to approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1	Overall Survival (OS)	Baseline until death from any cause (up to approximately 24 months)
Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1	Disease Control Rate (DCR)	First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)
Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1	Objective Response Rate (ORR)	Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)
Percentage of Participants with Adverse Events	Percentage of Participants with Adverse Events	Baseline until up to 21 days after end of treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Tang-Du Hospital; Yan'an University Affiliated Hospital
• Investigators: Study Chair: enxiao li, professor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Anlotinib; Non-squamous NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: XJTU1AF2018LSK-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No