UMIN-CTR Clinical Trial

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
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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	Completed
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	2020 Year 12 Month 18 Day

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