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

NCT ID: NCT03778853

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Advanced Non-squamous NSCLC

Keywords

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Non-squamous NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib Hydrochloride

Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

Group Type EXPERIMENTAL

Anlotinib Hydrochloride

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role lead

Responsible Party

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Chen Rui

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xiaoming hou, professor

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Central Contacts

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da zhao, professor

Role: CONTACT

Phone: 0086-13369287188

Email: [email protected]

rui chen, doctor

Role: CONTACT

Phone: 0086-13919899287

Email: [email protected]

Other Identifiers

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20180049

Identifier Type: -

Identifier Source: org_study_id