UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030399 |
|---|---|
| Receipt number | R000034710 |
| Scientific Title | Phase II study of afatinib for non-small cell lung cancer acquired resistance to osimertinib (North Japan Lung Cancer Study Group 1801) |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2019/06/16 13:30:30 |
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Basic information
Public title
Phase II study of afatinib for non-small cell lung cancer acquired resistance to osimertinib (North Japan Lung Cancer Study Group 1801)
Acronym
Phase II study of afatinib for NSCLC acquired resistance to osimertinib (NJLCG1801)
Scientific Title
Phase II study of afatinib for non-small cell lung cancer acquired resistance to osimertinib (North Japan Lung Cancer Study Group 1801)
Scientific Title:Acronym
Phase II study of afatinib for NSCLC acquired resistance to osimertinib (NJLCG1801)
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of afatinib for non-small cell lung cancer acquired resistance to osimertinib
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate
Key secondary outcomes
Progression free survival, Response rate, Duration of response, Overall survival, safety
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
Afatinib at the dose of 40 mg is orally administered once daily and the administration is continued until progression disease or unacceptable toxicity
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Non-small cell lung cancer (NSCLC)
2. EGFR activating mutation (exon 19 deletion or exon 21 L858R)
3. Detected T790M mutation before treatment with osimertinib
4. Stage IIIB, IV, or recurrent NSCLC
5. Have a history of first or second generation EGFR-TKI treatment
6. Progression disease after treatment with osimertinib
7. Have measurable lesion by RECIST version 1.1
8. ECOG performance status 0-1
9. Estimated life expectancy at least 4 months
10. Adequate organ function for treatment with afatinib
11. Written informed consent
Key exclusion criteria
1. ILD or pulmonary fibrosis complication on chest X-ray
2. Other cancers
3. With severe complication
1). Uncontrollable pericardial effusion, pleural effusion, or ascites
2). Uncontrollable diabetes
3). Uncontrollable hypertension, angina pectoris, or heart failure
4). SVC syndrome or spinal cord pressure symptom
5). Severe infectious disease
4. Impossible to take drugs orally
5. History of serious drug allergies
6. Pregnancy, breast feeding, or hesitation in contraception
7. Other conditions not suitable for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Iwate medical university
Division name
Division of pulmonary medicine, allergy, and rheumatology, Department of internal medicine
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
019-651-5111
maemondo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Heisuke Saito |
Organization
Iwate medical university
Division name
Division of pulmonary medicine, allergy, and rheumatology, Department of internal medicine
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
019-651-5111
Homepage URL
fkfmh744@ybb.ne.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | 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 | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034710
