UMIN-CTR Clinical Trial

Public title

Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapy

Acronym

Phase II Study of Nab-PTX/CBDCA for NSCLC previously treated with platinum

Scientific Title

Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapy

Scientific Title:Acronym

Phase II Study of Nab-PTX/CBDCA for NSCLC previously treated with platinum

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of Nab-PTX plus CBDCA as 2nd-line therapy in patients with stage IIIB/IV non-small-cell lung cancer previously treated with platinum-based chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Definitively diagnosed with non-small cell lung cancer by the specimens histologically or cytologically.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV
3) Prior chemotherapy is 1 regimen, which is platinum-based combination regimen (exclude EGFR-TKI and ALK inhibitor)
4) Age of 20 to 79 years
5) Without active cancer other than NSCLC
6) At least one measurable lesion
7) With adequate organ function
neutrophil count => 1,500/mm^3
platelet => 100,000/mm^3
hemoglobin => 9.0g/dL
AST/ALT < 2.5 times less than ULN
T.Bil <= 1.5mg/dL
serum creatinine <= 1.5mg/dL
ECG: without clinically problematic abnorbomalities
Peripheral neuropathy <= Grade 1
8) Life expectancy of at least 3 months
9) ECOG performance status 0 or 1
10) With written informed consent

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) Treated with radiotherapy within the past four weeks.
5) With a history of the treatment with taxane.
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 nab-paclitaxel, CBDCA
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

40

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Ishii

Organization

Dokkyo Medical University School of Medicine

Division name

Pulmonary Medicine and Clinical Immunology

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN

TEL

0282-87-2151

Email

ishiiysk@dokkyomed.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshiki Ishii

Organization

Dokkyo Medical University

Division name

Pulmonary Medicine and Clinical Immunology

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN

TEL

0282-87-2151

Homepage URL

Email

ishiiysk@dokkyomed.ac.jp

Institute

Dokkyo Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

06

Day

Last modified on

2013

Year

09

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013643