UMIN-CTR Clinical Trial

Basic information
Public title	A phase II, open label, single arm study to assess the efficacy of AZD9291 in patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy(WJOG8815L)
Acronym	A phase II study to assess the efficacy of AZD9291 in patients with locally advanced/metastatic non-small cell lung cancer with T790M mutation detected and quid biopsy and with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy(WJOG8815L)
Scientific Title	A phase II, open label, single arm study to assess the efficacy of AZD9291 in patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy(WJOG8815L)
Scientific Title:Acronym	A phase II study to assess the efficacy of AZD9291 in patients with locally advanced/metastatic non-small cell lung cancer with T790M mutation detected and quid biopsy and with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy(WJOG8815L)
Region	Japan

Condition
Condition	EGFR mutation positive advanced or metastatic NSCLC
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To demonstrate the efficacy of AZD9291 treatment in patients whose plasma harboring EGFR T790M+ confirmed with realtime PCR (Cobas EGFR mutation test v2, Roche Diagnostics GmbH)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Duration of Response, disease control rate, Tumor Shrinkage, progression free survival (PFS), oOverall survival (OS) and frequency and percentage of all adverse events (by grade)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Once-daily oral administration of 80 mg of AZD9291
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Provision of informed consent prior to any study-related procedures and testing. 2. Ages 20 years and over 3. Histological or cytological confirmation diagnosis of adenocarcinoma of the lung 4. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy 5. Radiological documentation of disease progression 6. Patients with at least one or more EGFR-TKI treatment regimens in prior treatment 7. Confirmation that the tumor harbors associated with any of EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) 8. Confirmation of tumor T790M mutation positive status, using real-time PCR (Cobas EGFR mutation test v.2.) or digital PCR (Bio-Rad Droplet digital PCR), from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen 9. WHO PS 0-1 with no deterioration over the 2 weeks prior to consent and a minimum life expectancy of 12 weeks 10. At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as 10mm or more in the longest diameter (except lymph nodes which must have short axis of 15mm or more) with CT or MRI 11. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential at screening
Key exclusion criteria	1.Involvement in the planning and/or conduct of the study 2.Treatment with any of the following: - Treatment with an EGFR-TKI within 8 days or approximately 5x half-life of the first dose of study treatment - Any cytotoxic chemotherapy within 14 days of the first dose of study treatment - Or previous treatment with a 3rd generation EGFR TKIs - Major surgery within 4 weeks of the first dose of study treatment - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study treatment - Patients currently receiving medications known to be potent inhibitors or inducers of cytochrome P4503A4(CYP3A4) - Treatment with an investigational drug within approximately five half-lives of the compound 3.Any unresolved toxicities from prior therapy greater than CTCAE grade 2 (with the exception of alopecia and G2, prior platinum-therapy related neuropathy) 4.Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment. 5.Any evidence of severe or difficult-to-control systemic diseases(difficult-to-control hypertension and active bleeding diatheses, hepatitis B, hepatitis C and HIV etc.) 6.Refractory nausea and vomiting, chronic gastrointestinal diseases or inability to swallow the formulated product or previous bowel resection, etc. that may significantly affect adequate absorption of investigational product 7.Patients with resting corrected QT interval more than 470 msec, any clinically important abnormalities in resting ECG, or any risk factors of QTc prolongation or arrhythmic events 8.Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD 9.Inadequate bone marrow reserve or organ function as demonstrated by any of the laboratory values 10.Women who are breast-feeding 11.History of malignant tumor
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiko Nakagwa
Organization	Kinki University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Email	nakagawa@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayuki Takahama
Organization	Kinki University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	takahama_t@dotd.med.kindai.ac.jp

Sponsor
Institute	Clinical trial coordinating committee for WJOG8815L investigator-initiated multicenter clinical trial
Institute
Department

Funding Source
Organization	AstraZeneca K.K
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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	2016 Year 04 Month 26 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	2015 Year 01 Month 31 Day
Date of IRB	2016 Year 02 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 23 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 04 Month 26 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025424