UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Acronym	Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Scientific Title	Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Scientific Title:Acronym	Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Region	Japan

Condition
Condition	Squamous cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine the recommended dose of nab-paclitaxel plus nedaplatin in chemo-naive patients with advanced squamous cell lung cancer and to assess the efficacy and safety with recommended dose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I: To determine the maximum tolerated dose and to estimate the recommended dose Phase II: response rate
Key secondary outcomes	Phase I: Safety, Response rate Phase II: Progression-free survival, Overall survival, safety

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	Phase I LEVEL2 nab-PTX: 100 mg/m2 (day1,8,15; q3w) CDGP: 100 mg/m2 (day1; q3w) LEVEL1 nab-PTX: 100 mg/m2 (day1,8, q3w) CDGP: 100 mg/m2 (day1; q3w) LEVEL0 nab-PTX: 100 mg/m2 (day1,8, q3w) CDGP: 80 mg/m2 (day1; q3w) LEVEL-1 nab-PTX: 80 mg/m2 (day1,8, q3w) CDGP 80: mg/m2 (day1; q3w) Phase II nab-PTX: RD, Recommended schedule CDGP: RD (day1; q3w)
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) Definitively diagnosed with squamous cell lung cancer by the specimens histologically or cytologically. 2) Stage III/IV without any indications for radiotherapy 3) No prior chemotherapy Adjuvant chemotherapy of UFT finished before 4 weeks from enrollment or more is permitted. 4) With a measurable lesion 5) Age of 20 to 75 years 6) Without active cancer other than NSCLC 7) ECOG performance status 0 or 1 8) With adequate organ function
Key exclusion criteria	1) Symptomatic brain metastasis 2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 3) With active double cancer or multicentric cancer 4) .>= G2 peripheral neuropathy (CTCAE) 5) Treated with radiotherapy within the past four weeks. 6) With clinically important complications. 7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem 8) With pleural effusion or pericardial effusion accumulates which need drainage 9) With the history of hypersensivity for component of human plasma with albumin, nab-PTX, or CDGP 10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 11) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kasai
Organization	Tochigi Cancer Center
Division name	Division of Thoracic Oncology
Zip code
Address	4-9-13 Yonan Utsunomiya City Tochigi
TEL	028-658-5151
Email	takasai@tcc.pref.tochigi.lg.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Kasai
Organization	Tochigi Cancer Center
Division name	Division of Thoracic Oncology
Zip code
Address	4-9-13 Yonan Utsunomiya City Tochigi
TEL	028-658-5151
Homepage URL
Email	takasai@tcc.pref.tochigi.lg.jp

Sponsor
Institute	Kanto respiratory disease study 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	2014 Year 02 Month 21 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	2013 Year 07 Month 29 Day
Date of IRB	2013 Year 07 Month 11 Day
Anticipated trial start date	2013 Year 07 Month 29 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 02 Month 21 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015425