UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Title of the study (Brief title)	Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Region	Japan

Condition
Condition	non-small-cell lung cancer with idiopathic interstitial pneumonias
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of carboplatin with nab-paclitaxel therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate (not necessarily with confirmation)
Key secondary outcomes	progression free survival, overall survival, time to treatment failure, response rate with confirmation, 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 with nab-paclitaxel
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) chemotherapy-naive histologically or cytologically confirmed stage IIIA,B/IV (TNM classification 8th version)or postoperative recurrent NSCLC 2) without history of radiotherapy for primary tumor 3) more than and equal to 20 years old 4) diagnosed with idiopathic interstitial pneumonias 5) with measurable lesions of tumors 6) ECOG performance status of 0-2 7) with no highly disabled organ functions
Key exclusion criteria	1) with interstitial pneumonias secondary to other conditions 2) with history of acute exacerbations of interstitial pneumonias within 3 months 3) with history of subacute exacerbations of interstitial pneumonias within 3 months 4) with usage of immunosuppressants 5) with peripheral neuropathy with Grade 2-4 6) with allergy to carboplatin, albumin, or taxane-based anticancer agents 7) with active infectious diseases 8) with active double cancers 9) with clinically important complications 10) with positivity of HBs antigen
Target sample size	32

Research contact person
Name of lead principal investigator	Toshihide Yokoyama
Organization	Kurashiki Central Hospital
Division name	Department of Respiratory medicine
Address	1-1-1 Miwa Kurashiki Okayama Japan
TEL	086-422-0210
Email	tk15127@kchnet.or.jp

Public contact
Name of contact person	Toshihide Yokoyama
Organization	Kurashiki Central Hospital
Division name	Department of Respiratory medicine
Address	1-1-1 Miwa Kurashiki Okayama Japan
TEL	086-422-0210
Homepage URL
Email	ty14401@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital Department of Respiratory medicine
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Other
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	倉敷中央病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 06 Day
Anticipated trial start date	2017 Year 04 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 26 Day
Last modified on	2017 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030659