Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)

An Open, Single-arm, Multi-center Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic 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: Advanced Non-squamous NSCLC
• Intervention / Treatment: Drug: Anlotinib Hydrochloride

Detailed Description

It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting 72 patients in the elderly without systemic 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): 72
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: da zhao, professor; Phone Number: 0086-13369287188; Email: Ydfyzhaohon@163.com
• Study Contact Backup: Name: rui chen, doctor; Phone Number: 0086-13919899287; Email: chrui-001@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed and dated informed consent
• Age：≥70
• 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

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
• 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 Hydrochloride; Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent	Drug: Anlotinib Hydrochloride; Anlotinib Hydrochloride ( 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 Name: AL3818

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progress free survival (PFS)	Time Frame: each 42 days up to PD or death(up to 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Until 30 day safety follow-up visit
OS	Overall Survival (OS)	From randomization until death (up to 24 months)
DCR	Disease Control Rate (DCR)	each 42 days up to intolerance the toxicity or PD (up to 24 months)
ORR	Objective Response Rate (ORR)	each 42 days up to intolerance the toxicity or PD (up to 24 months)
EORTC QLQ-C30	use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life	each 42 days up to intolerance the toxicity or PD (up to 24 months)

Collaborators and Investigators

• Sponsor: LanZhou University
• Collaborators: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: xiaoming hou, professor, LanZhou University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: December 15, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 15, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: 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: 20180049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No