UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease
Acronym	Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD
Scientific Title	Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease
Scientific Title:Acronym	Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of the combination of nab-Paclitaxel with Carboplatin for advanced non-small cell lung cancer patients with interstitial lung disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Exacerbation-free rate of ILD at 28 days after protocol treatment
Key secondary outcomes	Response rate, Progression-free survival, Overall survival, Exacerbation-free rate of ILD, Toxicities

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	4-6 cycles of chemotherapy with nab-Paclitaxl (100 mg/m2/day, day 1, 8, 15) and Carboplatin (AUC=6, day 1) repeated every 3 weeks
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) Histologically or cytologically proven non-small cell lung carcinoma 2) Clinical stage III, IV or recurrent disease after surgery 3) Diagnosed as interstitial lung disease 4) Severity of interstitial lung disease is mild or moderate 5) 20 years of age or older 6) ECOG performance status of 0 or 1 7) No prior chemotherapy for non-small cell lung cancer 8) No prior thoracic radiotherapy 9) With measurable or assessable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration 11) Adequate organ function 12) Estimated life expectancy of at least 12 weeks 13) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous active double malignancies 2) Other lung disease, including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vasucular disease 3) With symptomatic central nervous system metastases 4) Hypersensitvity to platinum or paclitaxel 5) Receiving systemic treatment with steroid or immunosuppressant 6) Positive for hepatitis B surface antigen 7) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the treatment period and lactating women. 8) Men who will not be compliant with a contraceptive regimen during and for the treatment period 9) Psychotic disorder which prevent the patient from giving informed consent 10) Other criteria judged by the investigator to make a patient unsuitable for the study
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Terufumi Middle name Last name Kato
Organization	Kanagawa Cancer Center
Division name	Department of Thoracic Oncology
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama 241-8515, Japan
TEL	045-520-2222
Email	katote@kcch.jp

Public contact
Name of contact person	1st name Hirotsugu Middle name Last name Kenmotsu
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka, Japan, 411-8777
TEL	055-989-5222
Homepage URL
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization	The study group on diffuse pulmonary disorders
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shizuoka Cancer Center IRB
Address	1007 Shimonagakubo, Nagaizumi-cho
Tel	0559895222
Email	h.kenmotsu@scchr.jp

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	国立がん研究センター中央病院（東京都）、横浜市立市民病院（神奈川県）、国立がん研究センター東病院（千葉県）、岡山大学（岡山県）、和歌山県立医科大学（和歌山県）、順天堂大学医学部附属順天堂医院（東京）、埼玉医科大学国際医療センター（埼玉県）、神奈川県立循環器呼吸器病センター（神奈川県）、静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 03 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	Main results already published
Date of protocol fixation	2013 Year 12 Month 16 Day
Date of IRB	2014 Year 04 Month 22 Day
Anticipated trial start date	2014 Year 06 Month 10 Day
Last follow-up date	2018 Year 01 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 28 Day
Last modified on	2020 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015086