UMIN-CTR Clinical Trial

Public title

Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer(OLCSG1303)

Acronym

Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer (OLCSG1303)

Scientific Title

Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer(OLCSG1303)

Scientific Title:Acronym

Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer (OLCSG1303)

Region

Japan

Condition

Non-small Cell Lung Cancer

Classification by specialty

Medicine in general	Pneumology	Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In phase 1 part, the feasibility of a weekly nab-PTX treatment are evaluated
and the recommended schedule are decided for advanced / recurrent non-small
cell lung cancer (NSCLC) as second- or third-line treatment (who had a
history of prior platinum-based chemotherapy).

In phase 2 part , the efficacy and safety are evaluated with the recommended
schedule in phase 1 part.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Objective Response Rate

Key secondary outcomes

safety and tolerability profile, progression-free survival, overall survival

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-PTX 100mg/m2 administration on day1, 8, 15, 22 intravenously q 4 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Histologicaly or cytologicaly confirmed advanced non-small cell lung cancer.
Wild type EGFR gene mutation (Unknown EGFR gene mutation status is allowed
for squamous cell carcinoma).
ALK fusion gene is negative or unknown.
One or two prior regimens containing a platinum-based chemotherapy.
Eastern Cooperative Oncology Group performance status 0-2.
Patient has measurable lesion(s) according to the RECIST ver.1.1 criteria
Adequate organ functions

Key exclusion criteria

a case who has a history of paclitaxel or nab-paclitaxel treatment.
a case with symptom(s) caused by brain metastasis or a case with meningeal
dissemination.
a case who has treated with thoracic radiotherapy within 4 weeks or
radiotherapy for other site(s) within 2 weeks
a case who has major concomitant disease as interstitial lung disease,
severe cardiac disease(unstable angina pectoris, history of myocardial
infarction, uncontrolled arrhythmia, severe diabetes mellitus, active
infection, HBV/ HCV hepatitis or liver cirrhosis )
a case who met contraindications on a nab-PTX package leaflet.

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Naoyuki Nogami

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

160 kou minamiumemoto-cho matsuyama-shi ehime pref.

TEL

81899991111

Email

nnogami@shikoku-cc.go.jp

Name of contact person

1st name
Middle name
Last name	Daijiro Harada

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of Thoracic Oncology

Zip code

Address

160 kou minamiumemoto-cho matsuyama-shi ehime pref.

TEL

81899991111

Homepage URL

Email

daharada@shikoku-cc.go.jp

Institute

Okayama Lung Cancer Study Group (OLCSG)

Institute

Department

Personal name

Organization

Okayama Lung Cancer Study Group (OLCSG)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

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

国立病院機構 四国がんセンター(愛媛県)、岡山大学病院（岡山県）､岡山赤十字病院（岡山県）、岩国医療センター（山口県）、神戸赤十字病院（兵庫県）、川崎病院（岡山県）、山口宇部医療センター（山口県）、中国中央病院（広島県）、岡山ろうさい病院（岡山県）、住友別子病院（愛媛県）、倉敷中央病院（岡山県）岡山医療センター（岡山県）、福山市民病院（広島県）、愛媛県立中央病院（愛媛県）

Date of disclosure of the study information

2013

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Partially published

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

Completed

Date of protocol fixation

2013

Year

11

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

26

Day

Last follow-up date

2017

Year

07

Month

11

Day

Date of closure to data entry

2017

Year

07

Month

27

Day

Date trial data considered complete

2017

Year

07

Month

27

Day

Date analysis concluded

2017

Year

08

Month

29

Day

Other related information

Registered date

2013

Year

11

Month

26

Day

Last modified on

2017

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014495