UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of erlotinib monotherapy for patients with advanced stage of non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immuno-staining with anti-EGFR mutation-specific antibodies.
Title of the study (Brief title)	OPH-RM/P-LC-1401
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate efficacy of erlotinib monotherapy for patients with inoperable advanced stage or recurrent non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immunostaining with anti-EGFR mutation-specific antibodies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival(PFS)
Key secondary outcomes	Response Rate(RR), 1-year survival rate, Overall Survival(OS), Time to treatment failure:TTF, Toxicities

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	Erlotinib monotherapy
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) Histologically or cytologically confirmed non-small cell lung cancer (2) 20 years-old or older (3) Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (4) No active EGFR mutation was detected by PNA-LNA PCR clamp method, and immunostainning was positive with anti-EGFR mutation-specific antibodies (Ex 19 deletion and Ex21 L858R point mutation). No additional biopsy was expected for sufficient specimen for EGFR mutation re-evaluation. (5) Liquid Based Cytology (ThinPrep) was used for pathological diagnosis and EGFR mutation detections. (6) Recurrence / progressive disease after prior chemotherapy for patients with ECOG PS 0-2. Chemo-na&iuml;ve or recurrence / Progressive disease after prior chemotherapy for patients with ECOG PS 3-4. (7) Evaluable disease (RECIST ver1.1), irrespective of measurable disease (8) No history of EGFR-TKI (9) Adequate organ function, evaluated within 14 days before enrollment as; ALT =or< 100IU/L and total bilirubin =or< 2.0mg/dL (10) Interval; one week after immunotherapy or hormone therapy, 2 weeks after pleurodesis with anti-tumor agent (11) Written informed consent
Key exclusion criteria	1. Problematic infection that requires anti-biotic, anti-fungal agent or anti-viral agent. 2. Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest CT or with clinical symptoms. 3. A history of severe hypersensitivity against erlotinib 4. Difficulty in oral administration of erlotinib, functional / organic impairment or inflammatory bowel disease that disturbs absorption of erlotinib 5. Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer. 6. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 7. Psychologically ineligible 8. Decision of ineligibility by a physician.
Target sample size	7

Research contact person
Name of lead principal investigator	Seigo Minami
Organization	Osaka Police Hospital
Division name	Dept. of Respiratory Medicine
Address	10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL	06-6771-6051
Email	seigominami@oph.gr.jp

Public contact
Name of contact person	Seigo Minami
Organization	Osaka Police Hospital
Division name	Dept. of Respiratory Medicine
Address	10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL	06-6771-6051
Homepage URL
Email	seigominami@oph.gr.jp

Sponsor
Institute	Dept. of Respiratory Medicine, Osaka Police Hospital
Institute
Department

Funding Source
Organization	Dept. of Respiratory Medicine, Osaka Police Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Dept. of Pathology, Osaka Police Hospital
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	大阪警察病院（大阪）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 18 Day
Anticipated trial start date	2014 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	2014 Year 06 Month 18 Day
Last modified on	2016 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016650