UMIN-CTR Clinical Trial

Public title

Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Acronym

Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Scientific Title

Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Scientific Title:Acronym

Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Erlotinib or S-1 as 3rd or 4th-line Chemotherapy for patients with non-small-cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Disease control rate

Key secondary outcomes

Overall survival
Progression free survival
Response rate
Safty

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1

Interventions/Control_2

Erlotinib

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)In 20-74 years of age at the time of consent.
2)Histologically or cytrologically confirmed diagnosis of non-small cell lung cancer.
3)Prior chemotherapy with more than two regimens, including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are not countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion.
4)Patients who have measurable lesion.
5)Eastern Cooperative Oncology Group(ECOG)Performance status 0-2.
6)Sufficient function of main organ( bone marrow,lung,liver,renal,heart)filled the following criteria.
White blood cell count>=3000/mm3
Absolute granulocyte count >= 1500/mm3
Hemoglobin >= 9.0g/dL
Platelet count >= 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST,ALT <100 IU/l
Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr
(or SpO2>=95%)
7)Life expectancy more than 3 months.
8)Written informed consent

Key exclusion criteria

1)Previous histories of drug allergy, which may increase the risk of this study.
2)Serious concomitant infection.
3)Usages of oral steroids or immunosuppressive drugs.
4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes.
5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
6)Patients with EGFR mutation or having past history of administration of EGFR tyrosine kinase inhibitors.
7)Severe pleural, abdominal or cardiac effusion.
8) Patients with symptomatic brain metastasis
9)Patients with active concomitant malignancy
10)Pregnant, lactating women.
11)Inappropriate patients judged by physicians

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Oizumi

Organization

Hokkaido University

Division name

Department of Respiratory Medicine

Zip code

Address

North 15,West7, Kita-ku, Sapporo060-8638, Japan

TEL

011-706-5911

Email

soizumi@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hajime Asahina

Organization

Hokkaido University

Division name

Department of Respiratory Medicine

Zip code

Address

North 15,West7, Kita-ku, Sapporo060-8638, Japan

TEL

011-706-5752

Homepage URL

Email

hajime.asahina@gmail.com

Institute

Hokkaido Lung Cancer Clinical Study Group

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

Date of disclosure of the study information

2011

Year

03

Month

25

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

Terminated

Date of protocol fixation

2011

Year

01

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

03

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

2011

Year

03

Month

25

Day

Last modified on

2016

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006313