UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Title of the study (Brief title)	Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior
Region	Japan

Condition
Condition	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 Erlotinib or S-1 as 3rd or 4th-line Chemotherapy for patients with non-small-cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease control rate
Key secondary outcomes	Overall survival Progression free survival Response rate Safty

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1
Interventions/Control_2	Erlotinib
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)In 20-74 years of age at the time of consent. 2)Histologically or cytrologically confirmed diagnosis of non-small cell lung cancer. 3)Prior chemotherapy with more than two regimens, including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are not countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion. 4)Patients who have measurable lesion. 5)Eastern Cooperative Oncology Group(ECOG)Performance status 0-2. 6)Sufficient function of main organ( bone marrow,lung,liver,renal,heart)filled the following criteria. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST,ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr (or SpO2>=95%) 7)Life expectancy more than 3 months. 8)Written informed consent
Key exclusion criteria	1)Previous histories of drug allergy, which may increase the risk of this study. 2)Serious concomitant infection. 3)Usages of oral steroids or immunosuppressive drugs. 4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6)Patients with EGFR mutation or having past history of administration of EGFR tyrosine kinase inhibitors. 7)Severe pleural, abdominal or cardiac effusion. 8) Patients with symptomatic brain metastasis 9)Patients with active concomitant malignancy 10)Pregnant, lactating women. 11)Inappropriate patients judged by physicians
Target sample size	60

Research contact person
Name of lead principal investigator	Satoshi Oizumi
Organization	Hokkaido University
Division name	Department of Respiratory Medicine
Address	North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL	011-706-5911
Email	soizumi@med.hokudai.ac.jp

Public contact
Name of contact person	Hajime Asahina
Organization	Hokkaido University
Division name	Department of Respiratory Medicine
Address	North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL	011-706-5752
Homepage URL
Email	hajime.asahina@gmail.com

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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 03 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 01 Month 24 Day
Anticipated trial start date	2011 Year 03 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 03 Month 25 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006313