UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014299
Receipt No. R000016650
Scientific Title 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.
Date of disclosure of the study information 2014/07/01
Last modified on 2016/08/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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.
Acronym OPH-RM/P-LC-1401
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
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
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
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)

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 大阪警察病院(大阪)

Other administrative information
Date of disclosure of the study information
2014 Year 07 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 Terminated
Date of protocol fixation
2014 Year 06 Month 18 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.