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Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020） | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

NCT03755869•First Affiliated Hospital Xi'an Jiaotong University

Summary

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Shaanxi Provincial Cancer Hospital

Xian, Shanxi, China

Key Dates

Start Date

November 29, 2018

Primary Completion Date

November 1, 2021

Completion Date

December 1, 2021

Last Updated

April 3, 2020

Enrollment

103

ESTIMATED participants

Conditions

Non-squamous NSCLC

Interventions

Anlotinib

DRUG

Contacts

enxiao li, professor

CONTACT

0086-13992819833 doclienxiao@sina.com

jingjing miao

CONTACT

0086-18392055301 miaojing0403@163.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: April 3, 2020Data 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.

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

Inclusion Criteria

Exclusion Criteria

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