UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer
Acronym	Intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Scientific Title	Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer
Scientific Title:Acronym	Intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I study:Safety Determine recommended dose Phase II study: Response rate
Key secondary outcomes	Safety Disease control rate Progression free survival Overall survival 1 year survival rate

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	Erlotinib plus Docetaxel
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	Phase1 1)Histologically or cytologically Non-small cell lung cancer 2)EGFR wild type of Exon 19 and 21 3)Unsuitable for surgery nor radiation therapy 4)Stage IIIB, or IV 5)Previously treated with one chemotherapy or chemoradiotherapy regimen 6)Aged 20 years and older 7)ECOG performance status 0-1 8)Adequate organ functions 9)Life expectancy of at least 3 months 10)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion 11)Written informed consent Phase2 1)Histologically or cytologically Non-small cell lung cancer 2)EGFR wild type of Exon 18, 19 and 21 3)Unsuitable for surgery nor radiation therapy 4)Stage IIIB, or IV 5)Previously treated with one chemotherapy or chemoradiotherapy regimen 6)Measurable lesion defined by RECIST ver1.1 7)Aged 20 years and older 8)ECOG performance status 0-1 9)Adequate organ functions 10)Life expectancy of at least 3 months 11)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion 12)Written informed consent
Key exclusion criteria	Phase1 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled infections or uncontrolled serious systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians Phase2 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled significant active infections or uncontrolled systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians
Target sample size	57

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinzoh Kudoh(Tatsuo Kimura)
Organization	Osaka City University Medical School
Division name	Department of Respiraory Medicine
Zip code
Address	1-4-3, Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3803
Email

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology 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)

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

Other administrative information
Date of disclosure of the study information	2009 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31242302
Number of participants that the trial has enrolled	60
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	2009 Year 02 Month 21 Day
Date of IRB	2009 Year 03 Month 26 Day
Anticipated trial start date	2009 Year 03 Month 01 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 03 Month 17 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002146