UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017709 |
|---|---|
| Receipt number | R000020464 |
| Scientific Title | A Study of Trastuzumab Emtansine in Patients With HER2-Positive, Recurrent Metastatic Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2018/05/30 22:34:37 |
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Basic information
Public title
A Study of Trastuzumab Emtansine in Patients With HER2-Positive, Recurrent Metastatic Non-Small Cell Lung Cancer
Acronym
HER2-CS-2 Study
Scientific Title
A Study of Trastuzumab Emtansine in Patients With HER2-Positive, Recurrent Metastatic Non-Small Cell Lung Cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Hotta |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1, Shikatacho, Kitaku, Okayama, Japan
TEL
086-223-7151
khotta@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Hotta |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1, Shikatacho, Kitaku, Okayama, Japan
TEL
086-223-7151
Homepage URL
khotta@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020464
