UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of Erlotinib with Cisplatin, Pemetrexed, and Bevacizumab for chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation
Title of the study (Brief title)	Quartet trial for chemo-naive advanced non-SQ NSCLC harboring EGFR mutation
Region	Japan

Condition
Condition	advanced non squamous non small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the dose limiting toxicity (DLT)To determine the maximum tolerated dose (MTD) and recomended dose (RD )of erlotinib and cisplatin, pemetrexed, and bevacizumab in chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	To examine the dose limiting toxicity (DLT)To determine the maximum tolerated dose (MTD) and recomended dose (RD )
Key secondary outcomes	efficacy, toxicity, PFS, OS

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	Level0: erlotinib (150mg/day) and cisplatin (50mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg) Level1: erlotinib (150mg/day) and cisplatin (60mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg) Level2: erlotinib (150mg/day) and cisplatin (75mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg) If none of the 3 patients who had been originally allocated to a dosage level experienced DLT, the dose of pemetrexed was increased to the next level. If one of the 3 patients experienced DLT at that level, 3 additional patients were enrolled for the further evaluation of toxicity. If two of 3 patients experienced DLT at that level, that dose was defined as the MTD. Furthermore, non or one patients experienced DLT at that level, the maximum dose was defined as the RD.
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)Histology/cytology-proven non-squamous non small cell lung cancer 2)NSCLC harboring mutations of EGFR 3)Stage IIIB, IV 4)Chemotherapy naive patients 5)Performance status(ECOG): 0-1 6)Adequate organ function 7)Written informed consent
Key exclusion criteria	1)Serious infections 2)Serious clinical problems 3)Interstitial pneumonia/lung fibrosis on chest CT 4)Active concomitant malignancy 5)Symptomatic brain metastasis 6)Massive pericardial, pleural effusion, ascites 7)Previous drug allergy 8)not adequated for bevacizumab 9)Those judged to be not suitable by the attending physician
Target sample size	12

Research contact person
Name of lead principal investigator	Ichiro Kawase
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name	Thoracic Malignancy
Address	3-7-1 Habikino Habikino City Osala Prefectural
TEL	+81729572121
Email	moto19781205@yahoo.co.jp

Public contact
Name of contact person	Motohiro Tamiya
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name	Thoracic Malignancy
Address	3-7-1 Habikino Habikino City Osala Prefectural
TEL	+81729572121
Homepage URL
Email	moto19781205@yahoo.co.jp

Sponsor
Institute	Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Institute
Department

Funding Source
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic diseases
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	2013 Year 12 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 11 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 09 Day
Last modified on	2018 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014522