UMIN-CTR Clinical Trial

Public title

Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.

Acronym

FONTANA

Scientific Title

Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.

Scientific Title:Acronym

FONTANA

Region

Japan

Condition

lung adenocarcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of erlotinib monotherapy for previously treated lung adenocarcinoma without activating EGFR mutation, EML4-ALK gene fusion, K-RAS mutation and MET protein over expression.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression-Free Survival (PFS)

Key secondary outcomes

Response Rate (RR), Overall Survival (OS), Safety, Quality of life (QOL)

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

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Erlotinib 150mg/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) Histologically or cytologically proven stage IIIB, IV or relapsed lung adenocarcinoma.
2) Tumor specimen is available for biomarker analysis
3) Patients without activating EGFR mutation, EML4-ALK fusion gene, K-Ras mutation and MET protein over expression
4) Patients who have previously treated chemotherapy
5) Measurable region evaluable according to the RECIST
6) ECOG performance status of 0-1
7) Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment
8) Patients aged 20 years or older
9) Sufficient function of main organ
10) Patients who are considered to survive for more than 3 months
11) Written informed consent

Key exclusion criteria

1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis
2) Patients with activating EGFR mutation or EML4-ALK fusion gene or K-Ras mutation or MET protein over expression
3) Patients with no history of chemotherapy for lung cancer
4) Patients with uncontrolled ascites, pleural effusion, or pericardial effusion
5) Patients with active severe infections
6) Patients with past history of administration of HER related agents
7) Impossible cases with oral administration
8) Patients with active ophthalmological disease
9) Pregnancy, breast feeding and suspected pregnancy
10) Patients with symptomatic brain metastasis
11) Patients with double cancer
12) Patients with uncontrollable diabetes mellitus
13) Patients with uncontrollable complications
14) Inappropriate patients for this study judged by the physicians

Target sample size

23

Name of lead principal investigator

1st name
Middle name
Last name	Kazuma Kishi

Organization

Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL

Division name

Department of Respiratory Medicine

Zip code

Address

2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN

TEL

03-3588-1111

Email

kazumak@toranomon.gr.jp

Name of contact person

1st name
Middle name
Last name	Hisashi Takaya

Organization

Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL

Division name

Department of Respiratory Medicine

Zip code

Address

Department of Respiratory Medicine

TEL

03-3588-1111

Homepage URL

Email

hisashi5240@yahoo.co.jp

Institute

Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Department of Respiratory Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

虎の門病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
栃木県立がんセンター（栃木県）
東邦大学医療センター大森病院（東京都）
JR東京総合病院（東京都）
順天堂大学医学部附属練馬病院（東京都）
順天堂大学医学部附属浦安病院（千葉県）

Date of disclosure of the study information

2013

Year

08

Month

07

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

Open public recruiting

Date of protocol fixation

2013

Year

04

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

08

Month

07

Day

Last modified on

2017

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013360