UMIN-CTR Clinical Trial

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
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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
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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
URL(English)	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

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