UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029763 |
|---|---|
| Receipt number | R000033810 |
| Scientific Title | Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study) |
| Date of disclosure of the study information | 2017/10/30 |
| Last modified on | 2019/06/03 10:33:39 |
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Basic information
Public title
Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Acronym
Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Scientific Title
Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Scientific Title:Acronym
Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
Region
| Japan |
Condition
Condition
EGFR mutation-positive non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of osimertinib treatment on EGFR T790M cytology positive non-small cell lung cancer patients who acquired resistance to EGFR tyrosine kinase inhibitors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall response rate: from first administration to last administration
Key secondary outcomes
1) disease control rate
2) progression-free survival
3) safety (adverse event)
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
Continue to administer osimertinib to a patient until the patient correspond to the withdrawal criteria
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) Non-small cell lung cancer (except for squamous cell carcinoma) diagnosed histologically or cytologically
2) Patients with EGFR mutation (Exon 19 deletion or Exon21 L858R) positive, who were received treatment by EGFR tyrosine kinase inhibitors
3) Patients with clinical stages IIIB, IIIC or IV or postoperative recurrence which are confirmed with diagnostic radiology
4) EGFR T790M positive cytology positive
5) Enrollment after 12 weeks from radiation therapy including lung area and after 1 week from radiation therapy not including lung area
6) Age: more than 20 years old at the date or informed consent
7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
8) Patients who have measurable lesion designated by RECIST version 1.1
9) Patients with adequate organ function
10) Enrollment after 21 days from the starting date of last cytotoxic anticancer agents or after 4 days from the last dose of EGFR tyrosine kinase inhibitors
11) Patients expected to survive for more than 12 weeks
12) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained
Key exclusion criteria
1) Treatment history of osimertinib or other third-generation EGFR tyrosine kinase inhibitors (ex. ASP8273)
2) Patients who received other EGFR-tyrosine kinase inhibitors again after disease progression
3) Treatment history of immune checkpoint inhibitors
4) QTc >470 msec
5) Patients with interstitial pneumonia, pulmonary fibrosis or radiation pneumonitis on chest CT
6) Patients with history of drug-related interstitial lung disease
7) Patients with history of serious drug allergy
8) Patients with serious infection or other serious concomitant disease (ex. gastrointestinal bleeding)
9) Uncontrollable pleural effusion, ascites or pericardial effusion
10) Clinically problematic heart disease
11) Uncontrollable diabetes
12) Central nervous system metastasis with a clinical manifestation
13) Patients with active double cancer
14) Clinically problematic psychiatric disorders
15) Unhealed fracture or heavy wound
16) Pregnant or breast-feeding female patients, female patients who have a possibility of pregnancy and does not intend to use birth control till after 6 weeks after last administration or male patients who does not intend to use birth control till after 4 months after last administration
17) Patients judged to be ineligible for safe implementation of this trial by the investigators
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Katakami |
Organization
Kobe City Medical Center General Hospital
Division name
Department of medical oncology
Zip code
6500047
Address
2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047
TEL
078-302-4321
katakami@fbri.org
Public contact
Name of contact person
| 1st name | Tatsushi |
| Middle name | |
| Last name | Goto |
Organization
Secretariat of clinical trial coordinating committee
Division name
none
Zip code
5300044
Address
Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka, 530-0044 Japan
TEL
06-6358-7110
Homepage URL
gotou@fiverings.co.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Department of medical oncology
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
独立行政法人国立病院機構 北海道がんセンター（北海道）、一般財団法人厚生会 仙台厚生病院（宮城県）、愛知県がんセンター中央病院（愛知県）、社会福祉法人京都社会事業財団 京都桂病院（京都府）、関西医科大学附属病院（大阪府）、独立行政法人国立病院機構 刀根山病院（大阪府）、大阪市立総合医療センター（大阪府）、神戸大学医学部附属病院（兵庫県）、地方独立行政法人大阪府立病院機構 大阪国際がんセンター（大阪府）、地方独立行政法人神戸市民病院機構 神戸市立医療センター中央市民病院（兵庫県）、兵庫県立がんセンター（兵庫県）、独立行政法人国立病院機構 四国がんセンター（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 30 | 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
6
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
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033810
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