UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)
Acronym	Phase 2 study of Carboplatin plus nab-Paclitaxel for PS 2 advanced NSCLC (TORG1426)
Scientific Title	Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)
Scientific Title:Acronym	Phase 2 study of Carboplatin plus nab-Paclitaxel for PS 2 advanced NSCLC (TORG1426)
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy and safety With combination of Carboplatin and nab-Paclitaxel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	6-month PFS rate
Key secondary outcomes	PFS, overall survival, response rate, desease control rate, toxicities, 1-year survival rate, QOL

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 (day 1, AUC=5) and nab-Paclitaxel(day 1, 8, 15, 70mg/m2) Q4weeks, maximum 6 courses.
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer 2) Clinical stage III (not amenable to curative radiation), IV or recurrent disease 3) patients without prior chemotherapy or curative radiotherapy for lung cancer 4) aged 20 - 74 years old 5) No matter EGFR or EML4-ALK mutation 6) patients who have at least one or more measurable lesion by RECIST v.1.1 7) ECOG (Eastern Cooperative Oncology Group) PS 8) Adequate organ function and laboratory findings as below(within 14 days prior registration); - WBC > 3,000/mm3 - neutrophil > 1,500/mm3 - platelet > 100,000/mm3 - hemoglobin > 9.0g/dl - AST, ALT < 100IU/L - total bilirubin < 1.5mg/dl - Ccr >45mL/min(Cockcloft-Gault mothod) - SpO2 > 90%(room air) 9) Life expectancy more than 2months 10) Symptomatic brain metastasis is allowed,if symptoms are comtrolled (14 days after surgery and/or radiotherapy) 11) Written informed consent
Key exclusion criteria	1) Patients with serious infection and/or serious complications(gastrointestinal bleeding, or cardiac disorder, etc) 2) Patients with interstitial pneumonia (by Chest X-P) 3) Patients with prior radiotherapy to primary and /or target region. 4) Patient who is with contraindications to paclitaxel or carboplatin. 5) History of hypersensitivity for albumin products 6) History of poorly controlled pleural effusion,pericardial effusion and ascites 7) Patients with severe renal dysfunction 8) Patients with symptomatic brain metastases 9) Patients with active double cancer less than 5 years disease free period 10) History of Bone-marrow transplantation 11) History of Peripheral blood stem cell transplantation(PBSCT) 12) Patients who declined contraception. 13) Patients with uncontrollable diabetes or hypertension 14) Patients with hepatic cirrhosis
Target sample size	42

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Nobuhiko Seki
Organization	Teikyo University, School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	nseki@med.teikyo-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yasuko Ichikawa
Organization	Teikyo University, School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	icchi@med.teikyo-u.ac.jp

Sponsor
Institute	NPO Thoracic Oncology Research 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	2015 Year 10 Month 22 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	Completed
Date of protocol fixation	2015 Year 03 Month 17 Day
Date of IRB	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 24 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021929