UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of Trastuzumab Emtansine in Patients With HER2-Positive, Recurrent Metastatic Non-Small Cell Lung Cancer
Title of the study (Brief title)	HER2-CS-2 Study
Region	Japan

Condition
Condition	HER2-positive, recurrent, non-small cell lung cancer (NSCLC)
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in patients with HER2-positive recurrent NSCLC
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall response rate (ORR)
Key secondary outcomes	Secondary endpoints: Safety, time to response, disease control rate, progression-free survival, overall survival, and patient's reported outcome with CareNote Explanatory analysis: biomarker analysis for investigating any potential markers related to resistance to T-DM1 using tumor specimens and blood samples

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Drug: trastuzumab emtansine 3.6 mg/kg trastuzumab emtansine will be given intravenously on Day 1 of each 21-day cycle. Treatment may continue until disease progression, unacceptable adverse events, or patient's wish.
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) Written informed consent (2) Age >= 20 years (3) Pathologically documented diagnosis of NSCLC (4) Tumor HER2 status of IHC 3+, IHC 2+ and FISH-positive, or insertion mutation in the exon 20 (5) Stage IIIB/IV not amenable to curative local treatment or postsurgical recurrent NSCLC (6) Prior treatment with at least one regimen of platinum-based chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment (History of resistance to the standard monotherapy is also accepted in patients aged 75 or older.) (7) Patients with a known mutation in the EGFR gene must have also experienced disease progression or intolerance with an EGFR-tyrosine Kinase Inhibitor (TKI). (8) Patients with a known ALK fusion oncogene must have also experienced disease progression or intolerance with an ALK-TKI. (9) Measurable disease determined as per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (10) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 (11) Adequate organ function (12) No prior use of T-DM1 Details are documented in the original protocol.
Key exclusion criteria	(1) History of intolerance or hypersensitivity to investigational agent or any excipient of the product (2) Current pregnancy or lactation (3) Refusal of use of highly effective contraception (4) Evidence of active pneumonitis during screening or its history, except for pulmonary fibrosis in the radiation field induced by prior thoracic irradiation (5) Left ventricular ejection fraction (LVEF) < 45% by echocardiogram (6) Current severe heart diseases (7) History of myocardial infarction or unstable angina within 6 months of enrollment (8) Current severe, uncontrolled systemic diseases (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) (9) Patients who have untreated, symptomatic, or uncontrollable CNS metastases (10) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (11) Current peripheral neuropathy of Grade >/= 3 per the Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0.3 (12) Patients who have had chemotherapy or radiotherapy within defined weeks prior to entering the study or those who have not recovered from adverse events due to agents administered early (13) Investigational therapy in another clinical study for therapeutic intent administered within 28 days before first study treatment (14) Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment (15) Current known active infection with HIV, hepatitis B, or hepatitis C virus (16) History of other malignancy within the last 5 years (17) Patients who cannot be hospitalized for at least 8 days from day1 in the first cycle Details are documented in the original protocol.
Target sample size	30

Research contact person
Name of lead principal investigator	Katsuyuki Hotta
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
Address	2-5-1, Shikatacho, Kitaku, Okayama, Japan
TEL	086-223-7151
Email	khotta@md.okayama-u.ac.jp

Public contact
Name of contact person	Katsuyuki Hotta
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
Address	2-5-1, Shikatacho, Kitaku, Okayama, Japan
TEL	086-223-7151
Homepage URL
Email	khotta@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 05 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 21 Day
Anticipated trial start date	2015 Year 05 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2018 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020464