UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013219
Receipt number R000015425
Scientific Title Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Date of disclosure of the study information 2014/02/21
Last modified on 2022/08/03 14:44:57

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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 or person

Institute

Kanto respiratory disease study group

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name