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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022077
Receipt No. R000025278
Scientific Title Observational study on detecting EGFR T790M mutation with multiple modalities in cell free DNA from advanced non small cell lung cancer patients (WJOG8815LPS)
Date of disclosure of the study information 2016/04/26
Last modified on 2019/05/07

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Basic information
Public title Observational study on detecting EGFR T790M mutation with multiple modalities in cell free DNA from advanced non small cell lung cancer patients (WJOG8815LPS)
Acronym EGFR T790M mutation analysis with cfDNA from NSCLC patients
Scientific Title Observational study on detecting EGFR T790M mutation with multiple modalities in cell free DNA from advanced non small cell lung cancer patients (WJOG8815LPS)
Scientific Title:Acronym EGFR T790M mutation analysis with cfDNA from NSCLC patients
Region
Japan

Condition
Condition Advanced non-small cell lung cancer with EGFR mutation
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To compare the detection, sensitivity, specificity, and concordance between assays to identify EGFR T790M mutations from circulating cell free DNA (cfDNA) in the peripheral blood plasma in patients with EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC) after they acquired EGFR-tyrosine kinase inhibitor (TKI) resistance.
Basic objectives2 Others
Basic objectives -Others To determine the power of detection and 95% confidence interval for ddPCR, cobas EGFR mutation test v2, and NGS, with respect to EGFR and T790M mutations that affect sensitivity to first- or second-generation EGFR-TKI treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary objective of this study is to determine the power of detection and 95% confidence interval for ddPCR, cobas EGFR mutation test v2, and NGS, with respect to EGFR and T790M mutations that affect sensitivity to first- or second-generation EGFR-TKI treatment.
Key secondary outcomes Levels of concordance, sensitivity, and specificity will be studied in an exploratory manner for ddPCR, cobas EGFR mutation test v2, and NGS, using ddPCR as the reference, with respect to EGFR and T790M mutations that affect sensitivity to first- or second-generation EGFR-TKI treatment.
Relationship between clinical demographics of patients in each of the somatic mutation positive groups (age, sex, PS at registration, histology, clinical stage, smoking status, etc.) and T790M mutation will be assessed using a logistic regression model.
Mechanisms involved in acquired resistance to EGFR-TKIs other than T790M mutation will be studied using NGS.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.Provision of informed consent prior to study-related procedures and testing.
2.Histological or cytological confirmation diagnosis of NSCLC.
3.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
4.Radiological documentation of disease progression.
5.Patients with at least one or more EGFR-TKI treatment regimens in prior treatment.
6.Confirmation that the tumor harbors an EGFR mutation known to be associated any of EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, and L861Q).
7.WHO performance status 0-1 with no deterioration over the 2 weeks prior to consent and minimum life expectancy of 12 weeks.
8.At least one unirradiated lesion that can be accurately measured at baseline as >= 10mm in the longest diameter (except for lymph nodes, which must have short axis of >= 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI).
Key exclusion criteria 1.Treatment history
*Third-generation EGFR-TKI
*Major surgery within 4 weeks of collection of plasma sample
*Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of collection of plasma sample.
2.Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
3.Spinal cord compression or brain metastases
4.Any evidence, as judged by the investigator, etc., of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
5.Refractory nausea and vomiting, chronic gastrointestinal diseases or inability to swallow the formulated product or previous bowel resection, etc.
6.Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
7.Inadequate bone marrow reserve or organ function within 28 days after registration
8.Women who are breast-feeding
9.Synchronous or metachronous (within 2 years) malignancies.
10.Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Nishio
Organization Kindai University
Division name Faculty of Medicine, Dept. of Genome Biology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511
TEL 072-366-0221
Email knishio@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304, 1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
2016 Year 04 Month 26 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 276
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
2016 Year 01 Month 31 Day
Date of IRB
2016 Year 03 Month 01 Day
Anticipated trial start date
2016 Year 02 Month 29 Day
Last follow-up date
2019 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2016 Year 04 Month 26 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025278

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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