UMIN-CTR Clinical Trial

Public title

PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

Acronym

PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

Scientific Title

PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

Scientific Title:Acronym

PhaseII study of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer acquired resistance to first line gefitinib monotherapy.

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of gefitinib combined with cisplatin and pemetrexed in patients with advanced non-squamous, non-small cell lung cancer
acquired resistance to first line gefitinib monotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

6 months progression free survival rate

Key secondary outcomes

Overall survival
Response rate
Progression free survival
Adverse events

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

Gefitinib combined with cisplatin plus pemetrexed followed by gefitinib monotherapy.

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 non-squamous non-small cell lung cancer.
2) Cytotoxic agents naive and clinical stage stage IIIB, IV (UICC-7) or recurrent disease after surgery. Measurable lesion is not necessary.
3,4) Harboring sensitizing EGFR mutation and acquired resistance to first line gefitinib monotherapy.
5) Age: over 20 years old.
6) ECOG performance status of 0 or 1.
7) Adequate organ function.
8) Life expectancy more than 12 weeks.
9) Written informed consent.

Key exclusion criteria

1) Impossible cases with protcol defined oral administration.
2) Patients with symptomatic brain metastasis.
3) With active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis.
4) Thoracic radiation, within 4 weeks, irradiation to other organs within 2 weeks.
5) Uncontrollable pleural or pericardial effusion.
6) Operation within 4 weeks.
7) Active infection.
8) Active concomitant malignancy.
9) Severe drug allergy.
10) Pregnant or breast-feeding woman.
11) Inappropriate patients for this study judged by the physicians.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Yamamoto

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code

Address

1007 Shimonagakubo Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hiroaki Akamatsu

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code

Address

TEL

Homepage URL

Email

h.akamatsu@scchr.jp

Institute

Division of Thoracic Oncology, Shizuoka Cancer Center

Institute

Department

Personal name

Organization

Division of Thoracic Oncology, Shizuoka Cancer Center

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

06

Month

02

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

30

Day

Date of IRB

Anticipated trial start date

2011

Year

06

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

06

Month

01

Day

Last modified on

2011

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006730