UMIN-CTR Clinical Trial

Public title

Phase II Study of Nab-paclitaxel and Carboplatin Plus
Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous
Non-Small-Cell Lung Cancer (ALCT004)

Acronym

Phase II Study of Nab-PTX and CBDCA Plus
Bev With Maintenance Bev As First-Line Chemotherapy for Reccurent or Advanced Non-sq NSCLC (ALCT004)

Scientific Title

Phase II Study of Nab-paclitaxel and Carboplatin Plus
Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous
Non-Small-Cell Lung Cancer (ALCT004)

Scientific Title:Acronym

Phase II Study of Nab-PTX and CBDCA Plus
Bev With Maintenance Bev As First-Line Chemotherapy for Reccurent or Advanced Non-sq NSCLC (ALCT004)

Region

Japan

Condition

Non-squamous non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of carboplatin plus nab-paclitaxel and bevacizumab in previously untreated stageIIIB/VI or postoperative recurrence non-squamous non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

response rate

Key secondary outcomes

overall survival,progression free survival, safety,QOL

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nab-paclitaxel(100mg/m2) on day1,8,15 plus carboplatin (AUC 6) and bevacizumab(15 mg/kg) on day1 given every 4 weeks for 4 cycles(max 6cycles). For patients with response or stable disease, bevacizumab(15mg/kg) on day1 every 3 weeks were continued until disease progression or unacceptable toxicity.

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Eligibility criteria for induction
1) Histologically or cytologically comfirmed non-squamous, non-small cell lung cancer
2) Stage IIIB/IV or postoperative recurrence Non-Sq NSCLC
3) Chemo-naive patients (contain EGFR-TKI and ALK-TKI)
* Recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy is acceptable.
* OK432 pleurodesis for malignant pleural effusion is acceptable.
4) Palliative radiotherapy (thorax excluded)
5) At least one measureable lesion per RECIST 1.0
6) Patients aged 20 or older, 75 under
7) ECOG performance status of 0 or 1
8) Adequate organ function within 2 weeks
* Leukocyte count > or = 3,000/mm3
* Neutrophil count > or = 1,500/mm3
* Platelet count > or = 100,000/mm3
* Hemoglobin concentration > or = 9.0 g/dl
* AST and ALT levels < or = 100IU/L
* Total bilirubin level < or = 1.5mg/dl
* Serum creatinine levels < or = 1.2mg/dl
* SpO2 > or = 92% (room air)
* Urinary protein < or = 1+
* Acceptable cardiac function
* Peripheral neuropathy < or = grade 1
9)Estimating Survival more than 3 months
10)Written informed consent

(2)Eligibility Criteria for maintenance therapy
1)Recover within 43 days after start of last cycle of induction therapy.
2)More than 3 cycles of induction chemotherapy and response criteria of induction chemotherapy achieved more than and equal to SD.
3)ECOG performance status of 0 or 1
4) Adequate organ function within 2 weeks
* Neutrophil count > or = 1500/mm3
* Hemoglobin concentration > or = 8.0 g/dl
* Platelet count > or = 100000/mm3
* AST and ALT levels < or = 100IU/L
* Total bilirubin level < or = 1.5mg/dl
* Serum creatinine levels < or = 1.5mg/dl
* SpO2 > or = 92% (room air)
* Peripheral neuropathy < or = grade 2
* Hypertension < or = grade 2
* proteinuria < or = grade 2
* any bleeding < or = grade 1
* thromboembolic event absence

Key exclusion criteria

1)SVC synd
2)Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free
3)Severe active infection and sever complication (gastrointestinal hemorrhage,cardiac disease)
4)Pregnant status or lactation
5)Uncontrolled psychiatric disease
6)History of allergic reaction for agents of present treatment
7)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
8)A history of significant hemoptysis (> 2.5 mL red blood per episode) before enrolment
9)Evidence of tumor invading large vessel on imaging, cavity and thrombus
10)History of thromboembolic events.Any history of cerebral, myocardial, and pulmonary infarction
11)Symptomatic brain metastasis
12)History of operation and biopsy within 4 weeks
13)Need to antiplatelet therapy or anticoagulation therapy without Aspirin 324 mg/day within 10 days
14)Bleeding tendency, blood coagulation disorder
15)Bowel obstruction
16)Current or previous history of gastrointestinal perforation and diverticulitis
17)Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia
18)Uncontrolled hypertension and diabetes
19)Other ineligible status judged by medical oncologist

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Takuama Yokoyama

Organization

Kyorin University School of Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

0422-47-5511

Email

taku@ks.kyorin-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takuma Yokoyama

Organization

Kyorin University School of Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

0422-47-5511

Homepage URL

Email

taku@ks.kyorin-u.ac.jp

Institute

Kyorin University School of Medicine

Institute

Department

Personal name

Organization

Kyorin University School of Medicine

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

Date of disclosure of the study information

2014

Year

03

Month

03

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

Enrolling by invitation

Date of protocol fixation

2013

Year

09

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

02

Day

Last modified on

2015

Year

09

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015526