UMIN-CTR Clinical Trial

Basic information
Public title	A Phase Ib study of osimertinib with ramucirumab in EGFR mutated lung adenocarcinoma patients. (LY3009806-IIT-01)
Acronym	Phase Ib study of osimertinib with ramucirumab (LY3009806-IIT-01)
Scientific Title	A Phase Ib study of osimertinib with ramucirumab in EGFR mutated lung adenocarcinoma patients. (LY3009806-IIT-01)
Scientific Title:Acronym	Phase Ib study of osimertinib with ramucirumab (LY3009806-IIT-01)
Region	Japan

Condition
Condition	To assess the efficacy and toxicity of Osimertinib plus ramucirumab
Classification by specialty	Pneumology Psychosomatic Internal Medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety, Efficacy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dose limiting toxicity (DLT)
Key secondary outcomes	Overall response rate (ORR) Progression-free survival (PFS) Overall survival (OS) Time to treatment failure (TTF) Safety

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	Osimertinib + ramucirumab
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) Pathologically confirmed, lung adenocarcinoma, with clinical stage IIIB, IV, or recurrence after curative surgery, or radiotherapy. 2) With EGFR sensitive mutation (exon 19 deletion, or exon 21 L858R) 3) Radiological progression was confirmed after the first or second generation EGFR-TKIs (gefitinib, erlotinib, afatinib, or dacomitinib), and EGFR T790M mutation was detected. 4) Aged more than 20 years at the time of study entry 5)ECOG performance status (PS) of 0-1 6) With measurable lesion 7) Adequate organ function
Key exclusion criteria	1) Any history of interstitial pneumonia, or any evidence of interstitial lung disease by CT scan. 2) Not able to swallow tablets. 3) Considered to be high risk of bleeding. 4) The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of protocol therapy 5) With serious illness or medical condition6) Undergone prior therapy, or procedure within defined period prior to enrollment 7) With local infection that requires procedure, or active systemic infection 8) HBS antigen (+) 9) Leptomeningeal carcinomatosis 10) Concurrent malignancy 11) Pregnant (must be negative serum pregnancy test or repeated urine test within 7 days prior to first dose), breast feeding, childbearing potential at enrollment, or not willing to use adequate contraceptive methods 12) Serious psychiatric condition that is hard to register this study 13) Known history of serious allergy 14) Other reason that the investigator would make the patient ineligible for entry into this study.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Yamamoto
Organization	Wakayama Medical University
Division name	Respiratory Medicine and Clinical Oncology
Zip code	641-8509
Address	Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL	073-441-0619
Email	nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Ozawa
Organization	Wakayama Medical University
Division name	Respiratory Medicine and Clinical Oncology
Zip code	641-8509
Address	Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL	073-441-0619
Homepage URL
Email	nbyamamo@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Eli Lilly and Company
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	Wakayama Medical University
Address	811-1, kimiidera
Tel	+81734410619
Email	wa-rinri@wakayama-med.ac.jp

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	和歌山県立医科大学附属病院（和歌山県）、神戸市立医療センター中央市民病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 28 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	6
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 09 Month 25 Day
Date of IRB	2017 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 11 Month 28 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 28 Day
Last modified on	2021 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034427