UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer
Title of the study (Brief title)	A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate efficacy and safety of Erlotinib as 2nd-line treatment after failure of first-line conbination therapy of Carboplatin/ Paclitaxel/ Bavacizumab for patients with StageIIIB/IV non- squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, Adverse events, Overall survival, Response rate of each EGFR status

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	Patients were given Erlotinib(150mg/day) until PD or appearing unacceptable toxity.
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	1)histologically or cytologically confirmed stage IIIB/IV non-squamous non-small-cell lung cancer 2)Patients who have previously treated with conbination therapy of Carboplatin/ Paclitaxel/ Bavacizumab 3)No prior treatment with HER related agents (gefitinib, lapatinib, trastuzumab, cetuximab, etc.). 4)Patient who has at least one or more measurable lesion by RECIST 5)Performance Status(ECOG) 0-2 6)Patients who can be hospitalized for 1-2 weeks after beginning of the treatment or under management to apply to it. 7)Patients aged 20-75 year old 8)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less. *Total bilirubin <=1.5mg/dL. *Serum creatinin, x 1.5 of ULN or less. *Electrocardiogram Nomal *SpO2 >=90% or SaPO2 >=65mmHg 9)Patients who are considered to survive for more than 3 months. 10)interval: (1) chemotherapy *More than 4 weeks after the last chemotherapy. *More than 2 weeks after the maintenance chemotherapy. (2) Radiation *More than 12 weeks after the thoracic irradiation or more than 1 weeks after the last irradiation to other organs. (3) Operation (including pleurodesis) *More than 2 weeks after the last operation 11)Patients providing written informed consent
Key exclusion criteria	1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis 2)Patients with active severe infections 3)Impossible cases with oral administration 4)Patients with active opthalmological disease 5)Pregnancy or lactation 6)Patients with active concomitant malignancy 7)Patients with uncontrollable diabetes mellitus 8)Patients with uncontrollable complications 9)Inappropriate patients for this study judged by the physicians
Target sample size	31

Research contact person
Name of lead principal investigator	Yoko Shibata
Organization	Yamagata University School of Medicine
Division name	Department of Cardiology, Pulmonology, and Nephrology
Address	2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
Email

Public contact
Name of contact person
Organization	Yamagata University School of Medicine
Division name	Department of Cardiology, Pulmonology, and Nephrology
Address	2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL	023-628-5302
Homepage URL
Email

Sponsor
Institute	Yamagata University School of Medicine
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	2011 Year 07 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 05 Month 16 Day
Anticipated trial start date	2011 Year 07 Month 01 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	2011 Year 07 Month 29 Day
Last modified on	2018 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007192