UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer.
Title of the study (Brief title)	Phase II study of alectinib and bevacizumab for ALK-positive NSCLC (NLCTG1501)
Region	Japan

Condition
Condition	ALK-positive non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the addition of bevacizumab to alectinib treatment in patients who had responded to alectinib and then showed disease progression.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall Survival, Overall Response Rate, Disease Control Rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alectinib Bevacizumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Non-small cell lung cancer proven by histology and/or cytology 2) ALK-rearrangement confirmed by FISH, IHC or RT-PCR 3) Patients who had responded to alectinib and showed disease progression 4) 20 years or older 5)At least one or more measurable lesion by RECIST ver1.1 6) Performance status (ECOG) 0 to 1 7) Adequate organ function 8)Life expectancy more than twelve weeks 9)Written informed consent
Key exclusion criteria	1)Have hemosputum more than 2.5ml 2)Evidence of bleeding diathesis 3)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging 4)Evidence of thombosis on imaging 5)Have had or require continuous administration of warfarin, heparin, or aspirin at the dose of more than 324mg per day. 6)Have uncontrolable hypertension 7)Have interstital pneumonia or idiopathic pulmonary fibrosis on CT 8)Have grade 2 or more non-hematological toxicity by alectinib 9)Have symptomatic brain metastases 10)Radiotherapy for primiary lesion 11)Have any severe disease complications 12)Have severe infection including hepatitis B which requires anti-virus agents. 13)Have a history of active double cancer 14)Have severe digestion and absorption disorder 15)Have severe mental disorder 16)Patients whose participation in the trial is judged to be in appropriate by the doctor
Target sample size	11

Research contact person
Name of lead principal investigator	Toshiaki Kikuchi
Organization	Niigata University Medical & Dental Hospital
Division name	Department of Respiratory and Infectious Diseases
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL	025-368-9326
Email	kikuchi@med.niigata-u.ac.jp

Public contact
Name of contact person	Satoshi Watanabe
Organization	Niigata University Medical & Dental Hospital
Division name	Department of Respiratory and Infectious Diseases
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL	025-368-9326
Homepage URL
Email	satoshi7@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 20 Day
Anticipated trial start date	2015 Year 06 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 05 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020652