UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015582 |
|---|---|
| Receipt number | R000018107 |
| Scientific Title | Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations. |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2018/11/05 10:43:43 |
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Basic information
Public title
Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations.
Acronym
NEJ025A
Scientific Title
Phase I trial of Afatinib intercalated with Carboplatin/Pemetrexed Chemotherapy in advanced non-squamous non-small-cell lung cancer harboring EGFR mutations.
Scientific Title:Acronym
NEJ025A
Region
| Japan |
Condition
Condition
1) Stage IIIB, IV or relapsed non-squamous cell carcinoma in non-small cell lung cancer
2) Harboring sensitive EGFR mutations
3) After progress disease of 1st line treatment by gefitinib or erlotinib
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine Maximum Tolerated Dose (MTD) of the combination therapy consisted of carboplatin (CBDCA), pemetrexed (PEM) and afatinib after failure of EGFR-TKI treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MTD, Dose Limiting Toxicity (DLT), Recomennded Dose (RD)
Key secondary outcomes
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
the combination therapy consisted of carboplatin (CBDCA), pemetrexed (PEM) and afatinib
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) Stage IIIB, IV or relapsed non-squamous cell carcinoma in non-small cell lung cancer
2) Harboring sensitive EGFR mutations
3) After progress disease of 1st line treatment by gefitinib or erlotinib
4) No prior treatment by cytotoxic chemotherapy
5) Performance Status (ECOG) 0, 1
6) Having adequate organ functions
a) neutrophil count >=1,500 /mm3
b) WBC >=3,000 /mm3
c) platelet >=100,000 /mm3
d) Hemoglobin >=9.0 g/dL
e) AST / ALT <=2.5 times of normal upper limit
f) Total bilirubin <=1.5
g) Serum creatinine <=1.5
h) Creatinine clearance >= 45mL/min (Cockcroft-Gault)
i) SPO2 >=93%
7) Life expectancy of more than 3 months
8) Written informed consent
Key exclusion criteria
1) Having problematic interstitial lung disease or lung fibrosis on chest CT
2) Having prior treatment(s) by afatinib and/or pemetrexed
3) Having persistent Grade >=2 non-hematological toxicity by gefitinib or erlotinib
4) Having uncontrollable pleural and/or peritoneal effusion
5) Having symptomatic brain metastasis
6) After radiotherapy for primary lesion
7) Having problematic complication(s)
8) Having infectious disease to be treated
9) Having active, double cancer
10) Having sever malabsorption syndrome
11) Pregnant women, or having possibility of pregnancy; man having no intent to birth control
12) Having psychological disorder
13) In addition, the primary doctor judging inappropriate for entry
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko Kobayashi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
1397-1 Yamane Hidaka-city, 350-1298, Japan
TEL
+81-42-984-4667
kobakuni@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
754 Asahimachi-dori, Niigata, 951-8510, Japan
TEL
+81-25-223-6161
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Maximum tolerated dose (MTD) was Level 1: afatinib 20mg/day with carboplatin AUC 5 and pemetrexed 500mg/m2.
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
The result was presented at WCLC 2017.
The results of this study was presented in "Watanabe S, Yamaguchi OU, Masumoto AI, Maeno Y, Kawashima Y, Ishimoto O, Sugawara S, Yoshizawa H, Kikuchi T, Nukiwa T, Kobayashi K. Phase I Study Evaluating the Combination of Afatinib with Carboplatin and Pemetrexed After First-line EGFR-TKIs. Anticancer Res. 2018;38(8):4699-4704."
Management information
Registered date
| 2014 | Year | 11 | Month | 01 | Day |
Last modified on
| 2018 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018107
