UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of CDDP/Alimuta combined with bevacizumab in patients with advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Acronym	ALPS trial
Scientific Title	Phase II study of CDDP/Alimuta combined with bevacizumab in patients with advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Scientific Title:Acronym	ALPS trial
Region	Japan

Condition
Condition	advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Classification by specialty	Medicine in general Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	efficacy and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	response rate, safety, overall survival, one-year-survial

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	chemotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients were eligible if they had histologically or cytologically proven unresectable locally advanced NSCLC (clinical stage 3 b with pleral effusion or stage 4, without a history of prior chemotherapy and radiotherapy. In addition, EGFR mutations were analyzed using the available tissue for diagnosis and patients without carrying EGFR mutations were enrolled in the study. Other criteria included the following: 1)age over20 and lessthan 75 years, 2) World Health Organization (WHO) performance status 0-2, 3) measurable disease and an estimated life expectancy over 3 months, 4) adequate bone marrow function (neutrophil count >2000/ul, hemoglobin 9 g/dl, platelets counts > 100,000/ul ), normal hepatic function (total bilirubin level < 1.5 times and AST < 2.5 times the upper normal limits), and renal function (creatinine <1.2 mg/dl, creatinine clearance > 45 ml/min), and partial oxygen tension over 60 torr.
Key exclusion criteria	1) pulmonary fibrosis on chest radiograph, 2)active infection, 3) severe heart disease, 4) past history of hypersensitivity to drugs, 5) pleural or pericardial effusion that required drainage, 6) brain metastasis or 7) pregnancy. Patients with a concomitant active malignancy were also excluded. Other concomitant anticancer therapy or experimental drug administration of any type was not permitted.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonobu Koizumi
Organization	Shinshu University School of Medicine
Division name	First Department of Internal Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2631
Email

Public contact
Name of contact person	1st name Middle name Last name Tomonobu Koizumi
Organization	Shinshu University School of Medicine
Division name	First Department of Internal Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2631
Homepage URL
Email

Sponsor
Institute	Department of Comprehensive Cancer Therapy, Shinshu Universituy School of Medicine
Institute
Department

Funding Source
Organization	public insurance
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	信州大学付属病院（長野県）

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 01 Day
Date of IRB	2009 Year 12 Month 08 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 05 Month 20 Day
Last modified on	2020 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004410