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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030206
Receipt No. R000034306
Scientific Title Randomized phase II study of osimertinib plus bevacizumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations (investigator-initiated multicenter clinical trial, WJOG9717L)
Date of disclosure of the study information 2017/12/01
Last modified on 2018/10/29

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Basic information
Public title Randomized phase II study of osimertinib plus bevacizumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations (investigator-initiated multicenter clinical trial, WJOG9717L)
Acronym Randomized phase II study for NSCLC(WJOG9717L)
Scientific Title Randomized phase II study of osimertinib plus bevacizumab and osimertinib for chemotherapy-naive patients with nonsquamous non-small cell lung cancer harboring EGFR mutations (investigator-initiated multicenter clinical trial, WJOG9717L)
Scientific Title:Acronym Randomized phase II study for NSCLC(WJOG9717L)
Region
Japan

Condition
Condition Nonsquamous non-small cell lung cancer harboring EGFR mutations untreated by chemotherapy
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To compare the efficacy and safety of osimertinib plus bevacizumab with those of osimertinib alone in patients with advanced nonsquamous non-small cell lung cancer harboring EGFR mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (assessed by central image reviewers)
Key secondary outcomes Progression-free survival (assessed by investigators), response rate, overall survival, incidence of adverse events

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 not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Osimertinib+Bevacizumab
Interventions/Control_2 Osimertinib
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 1) Histologically or cytologically confirmed nonsquamous NSCLC.
2) Confirmed EGFR mutations (exon 19 deletion, L858R) known to be associated with EGFR-TKI sensitivity with tumor tissue specimens or cytology specimens.
3) Absence of symptomatic brain metastases. Any brain metastasis with neurologic recovery by radiation therapy (corresponding to CTCAE v.4.0 grade 0 or 1) maintained for more than 2 weeks before enrollment (including the same day 2 weeks before) is acceptable.
4) Stage IIIB or IV not amenable to radical radiation therapy, or postoperative recurrence.
5) Age of 20 years or older at the time of informed consent.
6) ECOG performance status (PS) of 0 or 1
7) Presence of measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, excluding irradiated sites.
8) No prior chemotherapy for lung cancer (including EGFR-TKIs and immune checkpoint inhibitors).Any preoperative or postoperative chemotherapy given at least 6 months before enrollment in the present study is acceptable.
9) Absence of severe major organ involvement, with all of the following criteria met:
- Neutrophil count =>1500/mm3
- Hemoglobin =>9.0 g/dL
- Platelet count =>10.0x10,000/mm3
- PT-INR<=1.5
- AST <=100IU/L
- ALT <=100IU/L
- Total bilirubin <=1.5 mg/dL
- Creatinine <=1.5 mg/dL
- SPO2 =>90%(at room air)
- Urine protein <=1+
10) Written informed consent obtained from the patient after a sufficient explanation about the study given before enrollment in the study.
Key exclusion criteria 1)Active double cancers
2)Hemoptysis:
- Bloody sputum that occurs over 1 week
- Bloody sputum for which oral hemostatic drug was used continuously in the past 1 month or for which continuous use of oral hemostatic drug is required
- Bloody sputum for which injectable hemostatic drug was used in the past or for which use of injectable hemostatic drug is required
3) Highly likely to have the following bleeding complications:
- Bleeding tendency (coagulation disorder)
- Radiologically evident of tumor invasion of thoracic great vessels, cavitation of a lung lesion or thrombus
4) Antithrombotic drug that was used in the past 10 days or will be required during the study
5) Localized infection requiring surgical intervention or active systemic infection
6) Pregnant women, lactating women, women who may be pregnant, or women not intending to prevent pregnancy
7) Clinically significant psychiatric disorder that precludes the participation in the study
8) Continuous systemic administration of steroids at prednisolone-equivalent doses of >10 mg/day is required or current use of immunosuppressive drugs
9) History of serious hypersensitivity, or hypersensitivity to component of osimertinib or bevacizumab
10) Positive serum HBs antigen
11) Following concurrent or previous conditions:
- Symptomatic cerebrovascular accident
- Gastrointestinal perforation, fistula, or diverticulitis
- Difficult to take investigational drugs
- Symptomatic congestive heart failure or unstable angina, or previous myocardial infarction within 1 year before enrollment
- Mean QTc interval > 470ms, clinically severe arrhythmia, heart failure, hypokalemia , using medicine with risk of QTc prolongation or lethal arrhythmia
- Evident interstitial lung disease on CT, radiation pneumonitis
- Superior vena cava syndrome
- Spinal cord compression
- Untreated fracture or severe wound
- Uncontrolled peptic ulcer
- Hypertension uncontrolled by standard drug therapy (SBP >=150 mmHg or a DBP >=100 100 mmHg)
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Takahashi
Organization Shizuoka Cancer Center
Division name Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
TEL 055-989-5222
Email t.takahashi@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Kenmotsu
Organization Shizuoka Cancer Center
Division name Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
TEL 055-989-5222
Homepage URL
Email h.kenmotsu@scchr.jp

Sponsor
Institute Coordinating committee for WJOG 9717L investigator-initiated clinical study
Institute
Department

Funding Source
Organization AstraZeneca 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
2017 Year 12 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 19 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 04 Month 30 Day
Date analysis concluded
2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034306

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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