UMIN-CTR Clinical Trial

Basic information
Public title	Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)
Acronym	Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)
Scientific Title	Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)
Scientific Title:Acronym	Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Adult
Classification by malignancy	Malignancy
Genomic information	NO

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

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes	Safety, progression-free survival, overall survival

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	Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 3weeks. Carboplatin AUC 6 is administered by an infusion lasting 60 minutes on day 1 following to nab-paclitaxel 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age of 20 years or older and younger than 75 years 2) Histologically or cytologically confirmed non-small cell lung cancer 3) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 4) No prior chemotherapy 5) Patients with interstitial lung disease diagnosed by chest X-ray or Chest CT scan 6) Measurable lesion(s) 7) ECOG Performance status of 0-1 8) Sufficient major organ function 9) Life expectancy of at least 3 months 10) Written informed consent
Key exclusion criteria	1) History of Severe drug allergies 2) CVD-IP or other ILD (e.g. pneumoconiosis) with clear cause 3) Active infection 4) Oral steroid or immunosuppressant drug 5) Severe concurrent disease 6) Postive HBs antigen or positive HBs antibody with detectable HBV-DNA 7) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 8) Symptomatic brain metastasis 9) Active double cancer 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 11) Previous treatment with nab-paclitaxel 12) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Oizumi
Organization	Hokkaido University Schoole of Medicine
Division name	First Department of Medicine
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo
TEL	011-706-5911
Email	soizumi@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Asahina
Organization	Hokkaido University Schoole of Medicine
Division name	First Department of Medicine
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo
TEL	011-706-5911
Homepage URL
Email	asahinah@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Funding Source
Organization	Hokkaido Lung Cancer Clinical Study Group
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	Hokkaido University IRB
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
Tel	011-706-7636
Email	crjimu@huhp.hokudai.ac.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

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31654836
Number of participants that the trial has enrolled	36
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	2014 Year 01 Month 16 Day
Date of IRB	2014 Year 01 Month 20 Day
Anticipated trial start date	2014 Year 01 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 20 Day
Last modified on	2020 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015075