UMIN-CTR Clinical Trial

Public title

Phase I study of Erlotinib with Cisplatin, Pemetrexed, and Bevacizumab for chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation

Acronym

Quartet trial for chemo-naive advanced non-SQ NSCLC harboring EGFR mutation

Scientific Title

Phase I study of Erlotinib with Cisplatin, Pemetrexed, and Bevacizumab for chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation

Scientific Title:Acronym

Quartet trial for chemo-naive advanced non-SQ NSCLC harboring EGFR mutation

Region

Japan

Condition

advanced non squamous non small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the dose limiting toxicity (DLT)To determine the maximum tolerated dose (MTD) and recomended dose (RD )of erlotinib and cisplatin, pemetrexed, and bevacizumab in chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

To examine the dose limiting toxicity (DLT)To determine the maximum tolerated dose (MTD) and recomended dose (RD )

Key secondary outcomes

efficacy, toxicity, PFS, OS

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

Level0: erlotinib (150mg/day) and cisplatin (50mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg)
Level1: erlotinib (150mg/day) and cisplatin (60mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg)
Level2: erlotinib (150mg/day) and cisplatin (75mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg)

If none of the 3 patients who had been originally allocated to a dosage level experienced
DLT, the dose of pemetrexed was increased to the next level. If one of the 3 patients experienced DLT at that level, 3 additional patients were enrolled for the further evaluation of toxicity. If two of 3 patients experienced DLT at that level, that dose was defined as the MTD. Furthermore, non or one patients experienced DLT at that level, the maximum dose was defined as the RD.

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)Histology/cytology-proven non-squamous non small cell lung cancer
2)NSCLC harboring mutations of EGFR
3)Stage IIIB, IV
4)Chemotherapy naive patients
5)Performance status(ECOG): 0-1
6)Adequate organ function
7)Written informed consent

Key exclusion criteria

1)Serious infections
2)Serious clinical problems
3)Interstitial pneumonia/lung fibrosis on chest CT
4)Active concomitant malignancy
5)Symptomatic brain metastasis
6)Massive pericardial, pleural effusion, ascites
7)Previous drug allergy
8)not adequated for bevacizumab
9)Those judged to be not suitable by the attending physician

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Ichiro Kawase

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Division name

Thoracic Malignancy

Zip code

Address

3-7-1 Habikino Habikino City Osala Prefectural

TEL

+81729572121

Email

moto19781205@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Motohiro Tamiya

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Division name

Thoracic Malignancy

Zip code

Address

3-7-1 Habikino Habikino City Osala Prefectural

TEL

+81729572121

Homepage URL

Email

moto19781205@yahoo.co.jp

Institute

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

Institute

Department

Personal name

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic diseases

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

2013

Year

12

Month

10

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

Main results already published

Date of protocol fixation

2013

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

11

Day

Last follow-up date

2017

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

09

Day

Last modified on

2018

Year

06

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014522