UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004194
Receipt number R000005040
Scientific Title A randomized phase III study of continuous maintenance Bevacizumab with or without Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer whose EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known
Date of disclosure of the study information 2010/09/13
Last modified on 2021/10/08 16:34:38

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Basic information

Public title

A randomized phase III study of continuous maintenance Bevacizumab with or without Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer whose EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known

Acronym

Continuous maintenance of bevacizumab with or without pemetrexed for advanced non-squamous non-small cell lung cancer (COMPASS)

Scientific Title

A randomized phase III study of continuous maintenance Bevacizumab with or without Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab in patients with advanced non-squamous non-small-cell lung cancer whose EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known

Scientific Title:Acronym

Continuous maintenance of bevacizumab with or without pemetrexed for advanced non-squamous non-small cell lung cancer (COMPASS)

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the addition of Pemetrexed to Bevacizumab maintenance therapy would improve overall survival after Pemetrexed/Carboplatin/Bevacizumab

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival from the date of randomization for maintenance therapy

Key secondary outcomes

Progression free survival from the date of randomization for maintenance therapy, Overall Survival from the date of enrollment, Progression free survival from the date of enrollment, Adverse event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab

Interventions/Control_2

Bevacizumab with Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Induction therapy
1)Have non-squamous NSCLC and have not received any prior systemic chemotherapy including neoadjuvant /adjuvant therapy
with Stage IIIB, not candidate for curative radiotherapy, Stage IV or recurrence disease after surgery
a) Mixed type is classified into dominant histology but mixed small cell histology is not permitted
b) Regarding the patient who have or have had pleural effusion;
*A patient who requires treatment such as drainage of the pleural space is NOT eligible
*A patient who remains without pleural effusion for more than two weeks after drainage is eligible
*A patient with history of treatment with anticancer drugs (excluding BRM such as picibanil) for pleurodesis is NOT eligible
2)EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known
3)Have measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, but radiation-irradiated lesion is not this case.
4)Must be 20 or more years old at the time of consent.
5)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1
6)Have adequate organ function within one week before study entry
7)Have an estimated life expectancy of at least 90days
8)Have signed an informed consent document
Maintenance therapy
1)Meet eligibility criteria between day15 and day43 (day 1 is the date when patients receive last dose of induction therapy)
2)No evidence of Progressive disease on chest CT after the 4th cycle of induction chemotherapy. Brain metastasis should be evaluated with the same modality as used in the base line assessment (MRI or CT)
3)Have ECOG PS 0~1 at the time of randomization
4)Have adequate organ function within 1 weeks before randomization

Key exclusion criteria

Induction therapy
1)Have CNS metastasis. (A case with locally treated asymptomatic brain metastasis can be registered.)
2)Have received radiation therapy to lesions of lung
3)Currently have or have a history of a cardiac effusion which requires treatment
4)Have another active malignancy
5)Currently have or have a history of hemoptysis, or hemosputum as defined below;
a) continue hemosputum for more than one week
b) have had or require continuous oral administration of hemostat
c) have had or require injectable administration of hemostat
6)Have possibly complication related to bleeding episode
a) Have a bleeding diathesis
b) Have a evidence of involvement in major thoracic blood vassel
c) Have a evidence of cavitation in intra-thoracic lesion
d) Have a evidence of thrombosis
7)Have anti-thrombosis drugs within 10 days before enrollment or need them during the study
8)Currently have or have a history of the below disease;
a) Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment
b) Have ever had a history of gastrointestinal perforation or diverticulitis or fistula
c) Have symptomatic heart failure, unstable angina or arrhythmia which requires treatment, or have a history of cardiac infarction within one year before enrollment
d) Have any evidence of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis or pulmonary fibrosis on chest X-ray or with clinically active symptom, or have medical history of it
e) Currently have superior vena cava syndrome
f) Currently have a cord compression
g) Have a serious, nonhealing wound or unhealed bone fracture.
h) Have an uncontrollable ulcer
i) Have uncontrollable hypertension
j) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide
9)have a known sensitivity to any component of platinum drugs or monoclonal antibody drugs
10)Not have time interval described after prior therapies at the time of study entry
...etc.

Target sample size

620


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Seto

Organization

National Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code


Address

3-1-1, Notame, Minami-ku, Fukuoka, 811-1395, Japan

TEL

092-541-3231

Email

tseto@nk-cc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address

Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Eli Lilly Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 07 Month 17 Day

Date of IRB

2010 Year 06 Month 12 Day

Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2019 Year 02 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 13 Day

Last modified on

2021 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name