Anlotinib Plus Docetaxel for the Treatment of EGFR/ALK/ROS1 Mutation-negative Advanced Nonsquamous NSCLC

NCT03654027 | Unknown Phase 2

• 1 other identifier: ALTER-L019
• Study Type: interventional
• Target: 84
• 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 cell proliferation 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 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. Therefore,we envisage using anlotinib plus docetaxel treat the EGFR/ALK/ROS1 mutation-negative advanced nonsquamous Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progress free survival

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

Secondary Outcomes (4)

• OS

  From randomization until death (up to 24 months)

• ORR

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

• DCR

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

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

  Until 21 day safety follow-up visit

Study Arms (2)

Anlotinib Plus Docetaxel

EXPERIMENTAL

Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Drug: Anlotinib Plus Docetaxel

Docetaxel

ACTIVE COMPARATOR

Docetaxel (75mg/m2 IV d1)

Drug: Docetaxel

Interventions

Anlotinib Plus Docetaxel DRUG

Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Anlotinib Plus Docetaxel

Docetaxel DRUG

Docetaxel (75mg/m2 IV d1)

Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed and dated informed consent
• diagnosed with non squamous advanced NSCLC (phase IIIB/IIIC/IV) through pathology,with measurable nidus(using RECIST 1.1)
• have failed for platinum two drugs chemotherapy
• EGFR/ALK/ROS1 mutation-negative
• ECOG PS：0-1,Expected Survival Time: Over 3 months
• 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 2 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 2 months after it

You may not qualify if:

• Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
• squamous non small cell lung cancer （including adenosine squamous cell carcinoma ）
• have not used docetaxel before（except adjunctive therapy）
• iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
• patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
• patients are participating in other clinical studies less than 4 weeks from the end of a previous clinical study
• other kinds of malignancies within 5 years or for now
• 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 prothrombin time (PT) \> ULN + 4 seconds or APTT ULN \> 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
• urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
• uncontrollable hypertensive (systolic blood pressure or greater 160 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
• the effects of surgery or trauma had been eliminated for less than 14 days before admission to the study group
• patients with severe infections , and need to receive Systemic antibiotic treatment
• significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction （LVEF）Less than 50%
• patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• XIAOHUA HU, MD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XIAOHUA HU, MD

CONTACT

008613507719316; gxykdhxh@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: August 31, 2018

Record last verified: 2018-08