UMIN-CTR Clinical Trial

Public title

A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

Acronym

A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

Scientific Title

A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

Scientific Title:Acronym

A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate efficacy and safety of Erlotinib as 2nd-line treatment after failure of first-line conbination therapy of Carboplatin/ Paclitaxel/ Bavacizumab for patients with StageIIIB/IV non- squamous non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Progression free survival, Adverse events, Overall survival, Response rate of each EGFR status

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

Interventions/Control_1

Patients were given Erlotinib(150mg/day) until PD or appearing unacceptable toxity.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)histologically or cytologically confirmed stage IIIB/IV non-squamous non-small-cell lung cancer
2)Patients who have previously treated with conbination therapy of Carboplatin/ Paclitaxel/ Bavacizumab
3)No prior treatment with HER related agents (gefitinib, lapatinib, trastuzumab, cetuximab, etc.).
4)Patient who has at least one or more measurable lesion by RECIST
5)Performance Status(ECOG) 0-2
6)Patients who can be hospitalized for 1-2 weeks after beginning of the treatment or under management to apply to it.
7)Patients aged 20-75 year old
8)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
9)Patients who are considered to survive for more than 3 months.
10)interval:
(1) chemotherapy
*More than 4 weeks after the last chemotherapy.
*More than 2 weeks after the maintenance chemotherapy.
(2) Radiation
*More than 12 weeks after the thoracic irradiation or more than 1 weeks after the last irradiation to other organs.
(3) Operation (including pleurodesis)
*More than 2 weeks after the last operation
11)Patients providing 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 active severe infections
3)Impossible cases with oral administration
4)Patients with active opthalmological disease
5)Pregnancy or lactation
6)Patients with active concomitant malignancy
7)Patients with uncontrollable diabetes mellitus
8)Patients with uncontrollable complications
9)Inappropriate patients for this study judged by the physicians

Target sample size

31

Name of lead principal investigator

1st name
Middle name
Last name	Yoko Shibata

Organization

Yamagata University School of Medicine

Division name

Department of Cardiology, Pulmonology, and Nephrology

Zip code

Address

2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Yamagata University School of Medicine

Division name

Department of Cardiology, Pulmonology, and Nephrology

Zip code

Address

2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan

TEL

023-628-5302

Homepage URL

Email

Institute

Yamagata University School of 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

Date of disclosure of the study information

2011

Year

07

Month

30

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

05

Month

16

Day

Date of IRB

Anticipated trial start date

2011

Year

07

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

07

Month

29

Day

Last modified on

2018

Year

02

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007192