UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014299 |
|---|---|
| Receipt number | 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 13:23:11 |
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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-naïve 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
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
seigominami@oph.gr.jp
Sponsor or person
Institute
Dept. of Respiratory Medicine, Osaka Police Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016650
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