UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Title of the study (Brief title)	Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Region	Japan

Condition
Condition	Non-squamous Non-small-cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival Overall survival Disease control rate 1 year survival rate Adverse events

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	Carboplatin AUC=5 day 1+ Pemetrexed 500mg/m2 day 1+ Bevacizumab 15 mg/kg day 1 q3w 4 cycles followed by Pemetrexed 500mg/m2 day 1 + Bevacizumab 15 mg/kg day 1 q3w until disease progression
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically proven non-squamous non-small cell lung cancer 2) Non-squamous non-small-cell lung cancer harboring EGFR mutation 3) Stage IIIB, stage IV (UICC-7) or recurrent disease after surgery 4) Failure after the first-line EGFR TKI therapy 5) With measurable lesion (RECIST version 1.1) 6) Without previous radiotherapy to the primary tumor 7) Age: 20-74 years old 8) ECOG performance status of 0 or 1 9) Adequate organ function 10) Life expectancy more than 3 months 11) Written informed consent
Key exclusion criteria	1) Symptomatic brain metastasis 2) Hemoptysis (>=2.5ml) 3) Tumor invasion to the large blood vessel 4) Uncontrolled hypertension 5) Active infection 6) Severe underlying disease such as uncontrolled heart disease or diabetes mellitus 7) Receiving anticoagulants 8) Other concurrent active malignancy 9) Superior vena cava syndrome 10) Massive pleural or pericardial effusion, or ascites 11) Vertebral metastases requiring radiation therapy 12) Severe drug allergy 13) Active GI bleeding or inflammation in the abdominal cavity 14) Major surgery within 4 weeks 15) Pregnant or breast-feeding woman
Target sample size	27

Research contact person
Name of lead principal investigator	Hiroshi Saito
Organization	Aichi Cancer Center Aichi Hospital
Division name	Department of Respiratory Medicine
Address	18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan
TEL	0564-21-6251
Email	hsaito@acc-aichi.com

Public contact
Name of contact person	Kosuke Takahashi
Organization	Aichi Cancer Center Aichi Hospital
Division name	Department of Respiratory Medicine
Address	18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL	0564-21-6251
Homepage URL
Email	ktakahashi@acc-aichi.com

Sponsor
Institute	Central Japan Lung Study Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 12 Month 02 Day
Anticipated trial start date	2010 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 15 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005632