UMIN-CTR Clinical Trial

Public title

Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Acronym

Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Scientific Title

Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Scientific Title:Acronym

Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Region

Japan

Condition

advanced non-small cell lung cancer

Classification by specialty

Medicine in general	Pneumology	Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of continuous gefitinib with second line chemotherapy for elderly patients with EGFR sensitive mutation who failed the first gefitinib treatment for advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

progression free survival

Key secondary outcomes

disease control rate on 6th, 12th and 18th treatment week, overall survival, adverse effect

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A:Reference arm
Chemotherapy

Interventions/Control_2

B:Experimental arm
Chemotherapy plus EGFR-TKIs continuation

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Pathologically or cytologically confirmed non-small cell lung cancer.
2. Patients without previous EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment for non-small cell lung cancer.
3. Patients with clinical stage IIIB unsuitable for radiotherapy or Stage IV.
4. Patients who have confirmed EGFR mutation of exon 19 deletion or Exon 21 mutation.
5. Patients have previously treated with EGFR-TKIs (gefitinib, erlotinib or afatinib) as 1st-line chemotherapy, and have a disease control at least 8weeks. Registration within 42 days after the day of disease progression confirmation.
6. Patients with tolerable adverse effect during EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment
7. Age 70 year-old and over.
8. Patients with evaluable disease defined by RECIST.
9. ECOG performance status 0-2.
10. Sufficient organ function
Hb >=9.0 g/dL
WBC >=2000/mm3
Plt >=100000/mm3
GOT/GPT <=100IU/L
Cr =<1.5mg/dL
SpO2>=92%
11. Written informed consent.

Key exclusion criteria

1. Patients with difficulty of oral dosing continuation for 250mg gefitinib more than once in three days, more than 50 mg erlotinib every day or more than 100mg erlotinib every other day, or more than 20 mg afatinib every day.
2. Patients with active infection or uncontrollable disease.
3. Patients with clinically pulmonary disorders such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia or radioactive pneumonitis on chest CT.
4. Patients with induction or adjuvant chemotherapy within 12 months.
5. Patients with massive pleural effusion, ascites, pericardial effusion or SVC syndrome (drainage or pleurodesis with OK432 or bleomycin are permissive.)
6. Patients with symptomatic brain metastases or with treatment needs for steroids, anticonvulsant, etc.
7. Patients with severe drug allergy.
8. Patients with grade 3 or more diarrhea.
9. History of radiation therapy for mediastinum or lung.
10. History of active double cancer within 2 years.
11. Patients with hypersensitivity history or its suspicion to gefitinib, erlotinib and afatinib.
12. HBs antigen positive.
13. Patients who have possibility of pregnancy.
14. Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Sugio

Organization

Oita University Faculty of Medicine

Division name

Department of Thoracic and Breast Surgery

Zip code

Address

1-1, Idaigaoka, Hasama-machi, Yufu City, Oita, 879-5593, Japan

TEL

097-586-5854

Email

ksugio@oita-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masafumi Yamaguchi

Organization

National Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

3-1-1, Notame, Minamiku, Fukuoka City, 811-1395, Japan

TEL

092-541-3231

Homepage URL

Email

yamaguchi.m@nk-cc.go.jp

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN

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

飯塚病院（福岡県）
JCHO九州病院（福岡県）
九州大学（福岡県）
久留米大学（福岡県）
国立病院機構大牟田病院（福岡県）
国立病院機構九州医療センター（福岡県）
国立病院機構九州がんセンター（福岡県）
国立病院機構福岡東医療センター（福岡県）
浜の町病院（福岡県）
福岡大学（福岡県）
福岡大学　筑紫病院（福岡県）
福岡赤十字病院（福岡県）
佐賀県医療センター好生館（佐賀県）
佐賀大学（佐賀県）
長崎大学（長崎県）
日本赤十字社 長崎原爆病院（長崎県）
熊本大学（熊本県）
大分県立病院（大分県）
大分大学（大分県）
新別府病院（大分県）
川内市医師会立市民病院（鹿児島県）
沖縄県立南部医療センター・こども医療センター（沖縄県）
琉球大学（沖縄県）

Date of disclosure of the study information

2012

Year

05

Month

28

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

2011

Year

12

Month

03

Day

Date of IRB

Anticipated trial start date

2012

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

2012

Year

05

Month

25

Day

Last modified on

2016

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009450