UMIN-CTR Clinical Trial

Public title

Phase II study of combination chemotherapy of Carboplatin, Pemetrexed, Bevacizumab and Erlotinib in patients with advanced non-squamous non-small cell lung cancer harboring EGFR active mutation.

Acronym

Phase II study of 4-drug combination chemotherapy in patients with non-small cell lung cancer harboring EGFR active mutation.

Scientific Title

Phase II study of combination chemotherapy of Carboplatin, Pemetrexed, Bevacizumab and Erlotinib in patients with advanced non-squamous non-small cell lung cancer harboring EGFR active mutation.

Scientific Title:Acronym

Phase II study of 4-drug combination chemotherapy in patients with non-small cell lung cancer harboring EGFR active mutation.

Region

Japan

Condition

non-squamous non-small cell lung cancer harboring EGFR active mutation

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy and tolerability of combination chemotherapy using carboplatin and pemetrexed as cytotoxic agents, and bevacizumab as an anti-angiogenic agent in combination with erlotinib as one of standard therapies for non-squamous non-small cell lung cancer with active EGFR mutation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall Response Rate (ORR)
Disease Control Rate (DCR)
Overall Survival (OS)
Safety profiles

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four-drug combination chemotherapy of carboplatin, pemetrexed, bevacizumab and erlotinib

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

1, histologically or cytologically confirmed non-squamous non-small cell lung cancer
2, Stage IIIB, IIIC, IVA and IVB without indication of curative therapy or postoperative recurrent condition (UICC 8th)
3, EGFR active mutation i.e. exon 19 deletion or exon 21 L858R point mutation (a patient with complex mutations is excluded except for the combination of exon 19 deletion and exon 21 L858R point mutation)
4, One or more mesurable lesion(s)
5, chemotherapy-naive patient (Any preoperative or postoperative chemotherapy given at least 6 months before enrollment in the present study is eligible)
6, Aged 20 or older at the time of informed consent
7, Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
8, Adequate oral intake
9, Adequate organ function
10, All of the following criteria are met based on the latest data obtained within 14 days before enrollment:
1) Neutrophil count >= 1,500/mm^3
2) Hemoglobin >= 9.0 g/dL
3) Platelet count >= 10*10^4/mm^3
4) Total bilirubin <= 1.5 mg/dL (<= 2.0 mg/dl in case liver metastases is present)
5) AST(GOT) <= 2.5 X ULN and ALT(GPT) <= 2.5 X ULN (<= 5.0 X ULN if liver metastases is present)
6) Creatinine <= 1.5 X ULN
7) SpO2 >= 95% in room air or PaO2 is 80 torr or more.
8) Urinary protein is 1+ or less.
11, At the time of registration, the following period should elapse since the end of the following prior treatment:
Palliative radiation therapy: 2 weeks or more.
Surgical therapy (including examination or exploratory thoracotomy): 4 weeks or more.
Thoracic / cardiac drainage therapy: 2 weeks or more.
12, Estimated life expectancy should be more than 90 days from the date of registration.
13, Have given written consent to participate in the study after receiving detailed explanation of the study.

Key exclusion criteria

1, Evident pulmonary fibrosis or interstitial lung disease on chest X-ray
2, History of radiotherapy for primary lesion (Eligible if primary lesion is out of radiation field)
3, Presence or past history of hemoptysis (>= 2.5 ml)
4, Predisposing factor of airway bleeding i.e. disorder of coagulation, tumor invasion to major vessels, evident cavitary lesions, and tumor invasion of bronchus mucosa
5, Symptomatic central nervous system metastases
6, Active infectious disease (excluding viral hepatitis)
7, Severe complication (congestive heart failure, chronic renal failure, chronic liver failure, bleeding peptic ulcer, paralysis of intestine, ileus, uncontrollable diabetes mellitus, and so on)
8, Ascites or pleural effusion requiring drainage
9, Active double cancer
10, Elective surgery after enrollment of the study
11, Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy
12, Severe mental disorder
13, Severe drug hypersensitivity
14, Active hepatic disease
15, Any other condition unsuitable for enrolling the study judged by the attending doctor

Target sample size

35

Name of lead principal investigator

1st name	Takayasu
Middle name
Last name	Kurata

Organization

Kansai Medical University Hospital

Division name

Department of Thoracic Oncology

Zip code

573-1191

Address

2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan

TEL

072-804-0101

Email

kuratat@hirakata.kmu.ac.jp

Name of contact person

1st name	Hiroshige
Middle name
Last name	Yoshioka

Organization

Kansai Medical University Hospital

Division name

Department of Thoracic Oncology

Zip code

573-1191

Address

2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan

TEL

072-804-0101

Homepage URL

Email

hgyoshioka@gmail.com

Institute

North East Japan Study Group (NEJSG)

Institute

Department

Personal name

Organization

North East Japan Study Group (NEJSG)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kansai Medical University Hospital

Address

2-3-1 Shin-machi, Hirakata, 573-1191, Osaka, Japan

Tel

072-804-0101

Email

yoshihir@hirakata.kmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

関西医科大学附属病院、国立病院機構旭川医療センター、JCHO北海道病院、北海道大学病院、国立病院機構北海道医療センター、坂総合病院、宮城県立がんセンター、大曲厚生医療センター、一般財団法人慈山会医学研究所付属坪井病院、国立病院機構茨城東病院、佐野厚生総合病院、埼玉医科大学国際医療センター、埼玉医科大学病院、自治医科大学附属さいたま医療センター、総合病院国保旭中央病院、順天堂大学医学部附属練馬病院、江戸川病院、広島大学病院、県立広島病院、久留米大学病院などのNorth East Japan Study Group参加施設

Date of disclosure of the study information

2017

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

16

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

No longer recruiting

Date of protocol fixation

2017

Year

09

Month

07

Day

Date of IRB

2017

Year

10

Month

20

Day

Anticipated trial start date

2017

Year

11

Month

01

Day

Last follow-up date

2022

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2024

Year

10

Month

31

Day

Other related information

On February 25, 2019, the project was transferred to specific clinical research under the Clinical Research Act.

Registered date

2017

Year

10

Month

09

Day

Last modified on

2023

Year

10

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033413