UMIN-CTR Clinical Trial

Public title

Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.

Acronym

Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.

Scientific Title

Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.

Scientific Title:Acronym

Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.

Region

Japan

Condition

NSCLC

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of combination therapy with gefitinib and pemetrexed following progression with gefitinib monotherapy in EGFR mutation-positive patients with advanced non-small-cell lung cancer who not desire switchover to platinum-doublet chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, Response rate, Disease control rate, and safety

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

Administer gefitinib continuously at the dose of 250 mg, in principle, once daily until the discontinuation criteria are fulfilled. Administer pemetrexed by intravenous drip infusion at the dose of 500 mg/m2 once daily over 10 minutes and set a drug-withdrawal period at least for 20 days.

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. Diagnosed as having non small cell lung cancer by biopsy or cytology.
2. Stage IIIB or IV,in which radical irradiation is impossible, or postoperative recurrence.
3. Harboring EGFR mutation (exon 19 deletion, exon 21 L858R)
4. Clinical efficacy (CR PR SD and above 6 months) has already been obtained by administration of gefitinib as the first line treatment.
5. Gefitinib has already been administered as the first line treatment for above 6 months.
6. PD has been confirmed by imaging within 4 weeks prior to participation in this clinical study during the period of continuous administration of gefitinib as the first line treatment. However, when no PD findings have been confirmed in regions other than the head, such patients are judged as being ineligible as study subjects at that time point.
7. Subject with lesions evaluable by RECIST criteria.
8. Age at the time of obtaining informed consent is over 20 years.
9. ECOG Performance status (PS) is 0 to 2.
10. Major organ functions satisfying.
11. Survival for and above 12 weeks from the day of start of administration is expected.
12. Written consent has been obtained from patients themselves after adequate explanation of the study contents prior to their registration in this study. Particularly, patients who reject to receive platinum combination therapy after they have been explained that such switchover is the standard treatment, when they have been progressed by the first-line treatment with gefitinib.

Key exclusion criteria

1. Prior chemotherapy or other systemic anti-cancer treatment (excluding EGFR TKIs).
2. Not considered to require radiotherapy to the lung at the time of study entry or in the near future.
3. Patients with past history of acute lung disorder or interstitial pneumonia, drug-induced interstitial disease or radiation pneumonitis requiring steroid therapy. Or those presenting the signs of comorbidity of acute disorder or interstitial pneumonia, or those having clear interstitial pneumonia or pulmonary fibrosis on chest CT.
4. Patients with large amount of or uncontrollable pleural effusion/ascites/pericardial fluid.
5. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
6. Patients with past history of serious drug allergy.
7. Concomitant use of CYP3A4 inducers eg phenytoin, carbamazepine, rifampicin, barbiturates or St John's Wort.
8. Patients with serious infectious disease or other serious complications.
9. As judged by the investigator, any evidence of severe or uncontrolled systemic disease.
10. Patients with complication by poorly controllable diabetes mellitus.
11. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication.
12. Patients with active double cancer. Or those who have been diagnosed as having malignant tumor within the past 5 years.
13. Patients with clinically problematic mental disorder, etc.
14. Patients who are pregnant, lactating or may be pregnant, or those who have no intention of contraception.
15. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
16. Patients who are involved in the planning and practice of this study.
17. Previous enrolment or treatment in the present study.
18. Other patients who have been judged by attending physicians, etc. as being inappropriate for safe conduction of this study.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Miyako Satouchi

Organization

Hyogo Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

13-70, Kitaoji-cho, Akashi-shi, Hyogo, 673-8558,Japan

TEL

078-929-1151

Email

satouchi@hp.pref.hyogo.jp

Name of contact person

1st name
Middle name
Last name	Ken Uchibori

Organization

Tokyo Medical and Dental University

Division name

Department of Respirology

Zip code

Address

1-5-45,Yusima, Bunkyoku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

uchibori.pulm@tmd.ac.jp

Institute

Hanshin-Saga Collaborative Cancer Study Group

Institute

Department

Personal name

Organization

Astra Zeneca

Organization

Division

Category of Funding Organization

Profit organization

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

大阪府立成人病センター　（大阪府）
大阪府立呼吸器アレルギー医療センター　（大阪府）
関西医科大学枚方病院　　（大阪府）
神戸大学医学部　（兵庫県）
神戸市立医療センター中央市民病院　（兵庫県）
佐賀県立病院好生館　（佐賀県）
佐賀大学医学部 　（佐賀県）
先端医療センター　（兵庫県）　
刀根山病院 　（大阪府）
兵庫県立がんセンター　（兵庫県）
広島市民病院　（広島県）
山口宇部医療センター　（山口県）

Date of disclosure of the study information

2013

Year

05

Month

13

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

2013

Year

05

Month

17

Day

Date of IRB

2013

Year

03

Month

26

Day

Anticipated trial start date

2013

Year

05

Month

17

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

05

Month

13

Day

Last modified on

2021

Year

12

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012169