UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

khotta@md.okayama-u.ac.jp

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

Email

khotta@okayama-u.ac.jp

Institute

Okayama University Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

05

Month

27

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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