UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030206
Receipt number 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 2022/10/13 12:35:27

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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 Toshiaki
Middle name
Last name Takahashi

Organization

Shizuoka Cancer Center

Division name

Thoracic Oncology

Zip code

411-8777

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 Hirotsugu
Middle name
Last name Kenmotsu

Organization

Shizuoka Cancer Center

Division name

Thoracic Oncology

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

TEL

055-989-5222

Homepage URL


Email

h.kenmotsu@scchr.jp


Sponsor or person

Institute

Coordinating committee for WJOG 9717L investigator-initiated clinical study

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

West Japan Oncology Group

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

Completed

Date of protocol fixation

2017 Year 10 Month 06 Day

Date of IRB

2017 Year 11 Month 27 Day

Anticipated trial start date

2018 Year 01 Month 19 Day

Last follow-up date

2021 Year 07 Month 31 Day

Date of closure to data entry

2021 Year 11 Month 30 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2022 Year 05 Month 26 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 01 Day

Last modified on

2022 Year 10 Month 13 Day



Link to view the page

Value
https://center6.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