UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020242 |
|---|---|
| Receipt number | R000023226 |
| Scientific Title | A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study) |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2021/01/05 16:04:08 |
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Basic information
Public title
A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study)
Acronym
A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study)
Scientific Title
A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study)
Scientific Title:Acronym
A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study)
Region
| Japan |
Condition
Condition
advanced non-squamous non-small cell lung cancer harboring EGFR mutaiton
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficay of study treatment consisted of gefitinib and inserted cisplatin and pemetrexed comparing with gefitinib as a first-line treatment in patients with advenced non-squamous non-small cell lung cancer harboring EGFR mutation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival, response rate, adverse events, severe adverse events, proportion of EGFR T790M mutation positive in biopsy tisuues at disease progression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Gefitinib (ar a dose of 250 mg per day orally)
Interventions/Control_2
B:
1) Gefitinib (250 mg per day orally) was administrated on days 1-56.
2) Two-week drug free period.
3) Cisplatin (80 mg per suquare meter intravenously) and pemetrexed (500 mg per suquare meter intravenously) were administrated on days 71, 92, 113
4) Gefitinib was re-started on day 134.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Cytologically or histologically confirmed non-squamous non-small cell lung cancer [adenocarcinoma, large cell carcinoma (except for large cell neuroendocrine carcinoma), or non-small cell lung cancer not otherwise specified].
2) Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease.
3) Presence of EGFR activating mutation (exon 19 deletion or exon 21 L858R point mutation) and absence of EGFR exon 20 T790M point mutation. Absence of KRAS mutation (if checked).
4) Age of 20 to 74 years.
5) ECOG performance status 0-1.
6) Measureable or non-measureable.
7) No symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord metastasis requiring radiotherapy or surgical operation.
8) No superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites of grade 3 or more.
9) No history of surgical operation accompanied with organ resection within 28 days before registraion.
10) No prior radiotherapy to the metastasis of lung cancer within 14 days before registraion.
11) No prior systemic chemotherapy or definitive thoracic radiotherapy.
12) Adequate organ funcion
13) No findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
14) Written informed consent.
Key exclusion criteria
1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years.
2) Infectious disease requiring systemic treatment.
3) Pyrexia of 38 degrees centigrade or higher.
4) During pregnancy, within 28 days of postparturition, or during lactation.
5) Psychological disorder difficult to participate in this clinical study.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) Diabetes mellitus uncontrollable with the appropriate treatment.
8) Uncontrollable hypertension.
9) History of unstable angina pectoris or myocardial infarction within 6 months before registration.
10) Positive for serum hepatitis B surface antigen.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ohe |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511(2325)
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Kanda |
Organization
JCOG1404 Coordinating Office
Division name
Department of Thoracic Oncology, National Cancer Center Hospital
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511(2325)
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
West Japan Oncology Group (WJOG)
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
国立病院機構旭川医療センター（北海道）
国立病院機構北海道がんセンター（北海道）
北海道大学病院（北海道）
宮城県立がんセンター（宮城県）
仙台厚生病院（宮城県）
山形県立中央病院（山形県）
栃木県立がんセンター（栃木県）
国立病院機構渋川医療センター（群馬県）
群馬県立がんセンター（群馬県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
日本医科大学付属病院（東京都）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
国立国際医療研究センター病院（東京都）
がん研究会有明病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
帝京大学医学部（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
横浜市立市民病院（神奈川県）
北里大学医学部（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
石川県立中央病院（石川県）
金沢大学附属病院（石川県）
岐阜市民病院（岐阜県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部（愛知県）
愛知県がんセンター愛知病院（愛知県）
京都桂病院（京都府）
大阪府立急性期・総合医療センター（大阪府）
大阪市立大学医学部附属病院（大阪府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター（大阪府）
国立病院機構近畿中央胸部疾患センター（大阪府）
大阪市立総合医療センター（大阪府）
関西医科大学附属病院（大阪府）
市立岸和田市民病院（大阪府）
和泉市立病院（大阪府）
大阪医科大学附属病院（大阪府）
関西電力病院（大阪府）
大阪府済生会中津病院（大阪府）
兵庫県立がんセンター（兵庫県）
先端医療センター（兵庫県）
兵庫医科大学病院（兵庫県）
市立伊丹病院（兵庫県）
近畿大学医学部奈良病院（奈良県）
和歌山県立医科大学（和歌山県）
倉敷中央病院（岡山県）
岡山大学病院（岡山県）
岡山赤十字病院（岡山県）
広島大学病院（広島県）
国立病院機構山口宇部医療センター（山口県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
久留米大学医学部（福岡県）
九州大学病院（福岡県）
飯塚病院（福岡県）
長崎大学病院（長崎県）
大分県立病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted as intergroup study of Japan Clinical Oncology Group(JCOG) and West Japan Oncology Group(WJOG).
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
