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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015582
Receipt No. 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

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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
Last 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
Email kobakuni@saitama-med.ac.jp

Public contact
1st 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
Email satoshi7@med.niigata-u.ac.jp

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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