UMIN-CTR Clinical Trial

Public title

A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR

Acronym

Liquid biopsy study of afatinib.

Scientific Title

A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR

Scientific Title:Acronym

Liquid biopsy study of afatinib.

Region

Japan

Condition

EGFR mutated, advanced lung adenocarcinoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the concordance rate of EGFR mutation status between tumor tissue and serum.
To evaluate the correlation between the quantitativity of sensitive EGFR mutation in serum / de novo T790M in tumor tissue and radiological efficacy assessment.

Basic objectives2

Others

Basic objectives -Others

Concordance rate of EGFR mutation status between tumor tissue and serum before afatinib treatment.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Concordance rate of EGFR mutation status between tumor tissue and serum.

Key secondary outcomes

Clinical outcome;
overall response rate, progression-free survival, and safety

Biomarker analyses;
EGFR mutation analysis using digital PCR method; 1. Tumor tissue and serum (before and after afatinib treatment), and 2. quantitative monitoring in serum
Comprehensive analyses using next generation sequencing; tumor tissue and serum (before and after afatinib treatment)
EGFR mutation (exon 19 deletion) analysis using blocking oligo dependent PCR method; tumor tissue and serum (before and after afatinib treatment)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Afatinib 40mg/day

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) Pathologically confirmed lung adenocarcinoma
2) EGFR-TKI naïve, recurrence / advanced case
3) Activating EGFR mutation is confirmed by tumor tissue
4) The remaining tumor tissue is available for this study.
5) Age >= 20 years
6) ECOG performance 0-1
7) With measurable target lesion as per RECIST 1.1
8) With adequate organ function
9) Expecte survival time is more than 90 days.
10) Provided written informed consent

Key exclusion criteria

1) Incapable of oral intake
2) With intestinal paralysis, or ileus
3) Chronic diarrhea
4)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
5) Uncontrolled pleural / pericardial effusion, and ascites.
6) Symptomatic brain metastasis, or meningitis carcinomatosa.
7) Prior history of thoracic radiotherapy within 4 weeks
8) Prior surgery within 4 weeks
9) Active infection
10) Positive for HBs antigen
11) With severe complication
12) Concomitant cancers within 5 years
13) History of serious drug allergies
14) Patients requiring systemic steroid medication
15) With clinically problematic, psycho-neurologic diseases
16) Pregnancy, breast feeding, or hesitation in contraception
17) Other conditions not suitable for this study

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Yamamoto

Organization

Wakayama medical university

Division name

Third department of internal medicine

Zip code

Address

811-1, Kimiidera, Wakayama-city

TEL

073-441-0619

Email

nbyamamo@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

datacenter

Zip code

Address

Namba Plaza Bldg.3F 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

Boehringer Ingelheim

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

2014

Year

12

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31027689

Number of participants that the trial has enrolled

57

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

2014

Year

11

Month

22

Day

Date of IRB

2012

Year

12

Month

26

Day

Anticipated trial start date

2015

Year

02

Month

20

Day

Last follow-up date

2018

Year

06

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

04

Day

Last modified on

2019

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018406