UMIN-CTR Clinical Trial

Public title

Follow up analysis of phase III study of gefitinib versus erlotinib
in patients with advanced lung adenocarcinoma.

Acronym

Long term follow-up study of gefitinib vs erlotinib for lung adenocarcinoma

Scientific Title

Follow up analysis of phase III study of gefitinib versus erlotinib
in patients with advanced lung adenocarcinoma.

Scientific Title:Acronym

Long term follow-up study of gefitinib vs erlotinib for lung adenocarcinoma

Region

Japan

Condition

Previously treated advanced lung adenocarcinoma

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To confirm final overall survival of patients harboring EGFR mutation treated with gefitinib or erlotinib who were enrolled into WJOG5108L study.
To investigate the efficacy of EGFR-TKI for patients with brain metastasis according to treatment arm who were enrolled into WJOG5108L study.

Basic objectives2

Others

Basic objectives -Others

1.Final overall survival
1)All eligible patients
2)Patients harboring activating mutation
3)Patients with brain metasitasis
4)Patients with brain metastasis and activating mutation
2. Final progression free survival
1)All eligible patients
2)Patients harboring activating mutation
3)Patients with brain metasitasis
4)Patients with brain metastasis and activating mutation
3. Response rate
1)Response rate of brain metastasis according to treatment arm
2)Response rate of brain metastasis in patients with activating mutation accord to treatment arm

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival of patients with activating mutation according to treatment arm

Key secondary outcomes

Efficacy of brain metastasis in patients with brain metastasis according to treatment arm

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

Patients expressing informed consents with WJOG5108LFS study who were enrolled into original WJOG5108L study

Key exclusion criteria

none

Target sample size

561

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Katakami

Organization

Kobe City Medical Center General Hospital

Division name

Medical Oncology

Zip code

Address

2-1-1 Minatojima Minamimachi Cyuo-ku Kobe City, Hyogo.

TEL

+81-78-302-432

Email

nkatakami@kcho.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

Fund of Nonprofit Foundation Institute of Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2017

Year

11

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

2017

Year

10

Month

06

Day

Date of IRB

2017

Year

10

Month

31

Day

Anticipated trial start date

2017

Year

12

Month

01

Day

Last follow-up date

2020

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Analysis of OS and PFS according to treatment arms were performed for the following cases;
1) all eligible cases
2) case harboring activating mutation
3) case harboring L858R
4) case harboring exon 19 del
5) case with brain metastasis
6) case with brain metastasis and activating mutation.

Survival curves (PFS and OS) were analyzed by the Kaplan Meier method and were compared between groups by the Cox regression model and log-rank test. The 95% CIs for median PFS and OS were calculated using the Brookmeyer and Crowley method. Subgroup analyses for PFS and OS were performed to examine the interaction effect of treatment arm with each of the following factors: gender, age (<65 years old vs >65 years old, stage (stage IIIB, IV, postoperative recurrence), smoking status (never smoker or light smoker, ever-smoker), treatment line (2nd line, 3rd line or later), brain metastasis (yes, no), EGFR status (EGFR mutation positive, EGFR wild type)

Tumor response for brain metastasis of the following cases was compared between the two treatment arms using the x2 test;
1) case with brain metastasis at the time of treatment
2) case with brain metastasis and EGFR mutation at the time of treatment

Registered date

2017

Year

11

Month

22

Day

Last modified on

2023

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034345