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

NCT03778853 | Unknown Phase 4

• 1 other identifier: 20180049
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Non-squamous NSCLC

Keywords

Non-squamous NSCLC

Outcome Measures

Primary Outcomes (1)

• PFS

  Progress free survival (PFS)

  Time Frame: each 42 days up to PD or death(up to 24 months)

Secondary Outcomes (5)

• OS

  From randomization until death (up to 24 months)

• DCR

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• ORR

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Until 30 day safety follow-up visit

• EORTC QLQ-C30

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

Anlotinib Hydrochloride

EXPERIMENTAL

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

Interventions

Anlotinib Hydrochloride 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

Anlotinib Hydrochloride

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LanZhou University: lead
• General Hospital of Ningxia Medical University: collaborator

Study Officials

• xiaoming hou, professor

  LanZhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

da zhao, professor

CONTACT

0086-13369287188; Ydfyzhaohon@163.com

rui chen, doctor

CONTACT

0086-13919899287; chrui-001@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12