UMIN-CTR Clinical Trial

Basic information
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
Condition	NSCLC
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, Response rate, Disease control rate, and safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Hanshin-Saga Collaborative Cancer Study Group
Institute
Department

Funding Source
Organization	Astra Zeneca
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date	2013 Year 05 Month 13 Day
Last modified on	2021 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012169