UMIN-CTR Clinical Trial

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

Advanced non-small cell lung cancer with EGFR mutation

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

West Japan Oncology Group

Institute

Department

Personal name

Organization

AstraZeneca K.K

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Nothing particular

Registered date

2016

Year

04

Month

26

Day

Last modified on

2020

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025278