UMIN-CTR Clinical Trial

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

Non small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

6-month PFS rate

Key secondary outcomes

PFS, overall survival, response rate, desease control rate, toxicities, 1-year survival rate, QOL

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

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

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

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

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

Institute

NPO Thoracic Oncology Research Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2015

Year

10

Month

22

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

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 related information

Registered date

2015

Year

10

Month

22

Day

Last modified on

2019

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021929