UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017906 |
|---|---|
| Receipt number | R000020743 |
| Scientific Title | A phase II, multicenter, single-arm study of Induction therapy with LDK378 followed by surgery in patients with ALK fusion-positive Stage II/III non-small cell lung cancer. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/12/17 11:12:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II, multicenter, single-arm study of Induction therapy with LDK378 followed by surgery in patients with ALK fusion-positive Stage II/III non-small cell lung cancer.
Acronym
SAKULA trial
Scientific Title
A phase II, multicenter, single-arm study of Induction therapy with LDK378 followed by surgery in patients with ALK fusion-positive Stage II/III non-small cell lung cancer.
Scientific Title:Acronym
SAKULA trial
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative therapy with LDK378 in patients with ALK fusion gene-positive stage II/III non-small cell lung cancer (NSCLC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Major pathological response rate
Key secondary outcomes
･Incidence of adverse events
･Relapse-free survival: RFS
･Overall survival: OS
･Response rate: RR
･Pathological complete response rate: pCR rate
･Operability
･Complete resection rate
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 | Maneuver |
Interventions/Control_1
A treatment cycle is defined as 28 days from the start of LDK378. 750 mg of LDK378 is orally administered once daily. After preoperative induction treatment with LDK378 for 3 cycles, surgical resection is performed. For postoperative adjuvant treatment, LDK378 is orally administrated for 13 cycles (1 year).
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)Histologically or cytologically confirmed diagnosis of NSCLC.
2)ALK fusion gene is determined to be positive by at least 2 of the following methods: FISH, immunohistochemical (IHC) examination, and RT-PCR .
3)Clinical stage is II or III
4)It is considered that complete tumor removal can be achieved by pneumonectomy (lobectomy or more extensive surgical resection) and by lymph node dissection.
5)Predicted residual FEV1 after resection is >= 800 ml.
6)No previous treatment.
7) Male or female aged 20 years and over.
8)Performance status (ECOG) is 0 or 1.
9) At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumor) ver1.1.
10)The following laboratory values indicative of adequate organ functions are available within 7 days before registration:
a. Neutrophil count >= 1,500/mm3
b. Platelet count >= 100,000/mm3
c. Hemoglobin (Hgb) >= 10.0 g/dL
d. Serum albumin >= 3.0 g/dL
e. Creatinine clearance >= 30 mL/min
f. Total bilirubin <= 1.5 mg/dL (total bilirubin <= 3.0 mg/dL in patients with Gilbert's syndrome)
g. AST (SGOT) <= 100 IU/L
h. ALT (SGPT) <= 100 IU/L
i. ALP <= 1800 IU/L
j. Amylase <= 300 U/L
k. Lipase <= 57U/L
l. Fasting plasma glucose <= 175 mg/dL ( <= 9.8 nmol/L)
m. Potassium <= 5.0 mEq/L
n. Magnesium <= 10.0 mg/dL
o. Phosphorus <= 4.5 mg/dL
p. Calcium <= 10.0 mg/dL
q. SpO2 >= 93%
11)Women of child-bearing-potential show a negative result of pregnancy test conducted within 7 days before registration. Both male and female patients agree to use an appropriate method of contraception during the study and for 3 months after discontinuation of the study drug.
12)Patients expected to survive for at least 3 months after the first day of preoperative chemotherapy.
13)Patients intended and able to comply with scheduled study visit, treatment plan, laboratory tests, and other study-related procedures.
Key exclusion criteria
1) Patient with lymph node metastasis in the neck/ lymph node metastasis in the supraclavicular/ contralateral hilus and contralateral mediastinum.
2) Patient having previously experienced hypersensitivity to any additive of LDK378.
3) Patient with a history of or currently having malignant tumors other than NSCLC.
4) Patient with a history of interstitial lung disease or interstitial pneumonia.
5) Patient with any of the following clinically significant and poorly controlled heart diseases:
-Unstable angina pectoris and Myocardial infarction within 6 months before registration
-A history of congestive heart failure
-Poorly controlled hypertension defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg
-Arrhythmia not controlled with drugs
-QT interval > 470 msec on ECG
6) Patient with poorly controlled diabetes mellitus.
7) Patient receiving any of the following drugs and in whom it is impossible to discontinue them for at least 1 week before the start of treatment with LDK378:
-Potent CYP3A4/5 inhibitor or inducer
-Drugs with a small therapeutic index that are mainly metabolized by CYP3A4/5, CYP2C8 or CYP2C9
-Drugs known to prolong QT interval or induce Torsades de pointes
8) Patient receiving warfarin sodium or other coumarin anticoagulants.
9) Patient treated with corticosteroids at unstable doses.
10) Patient receiving enzyme-inducing anticonvulsants and in whom it is impossible to discontinue them for at least 1 week before the first administration of LDK378.
11) Pregnant women or breast-feeding women.
12) Patients with any major acute or chronic medical or mental condition or laboratory abnormality that is considered to increase the risk associated with participation in the study by the investigator.
14) Functional gastrointestinal tract disorder/ gastrointestinal disease that significantly prevents absorption of LDK378.
15) Patient has a history of pancreatitis/ increased amylase or lipase that was due to pancreatic disease.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Divisions of Thoracic Oncology
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
sakula_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kiyotaka ,Yoshitaka |
| Middle name | |
| Last name | Yoh, Zenke |
Organization
National Cancer Center Hospital East
Division name
Divisions of Thoracic Oncology
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
sakula_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center HospitalEast
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of National Cancer Center Hospital
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irboffice@east.ncc.go.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
国立がん研究センター東病院（千葉県）
北海道大学病院（北海道）
大阪市立総合医療センター（大阪府）
四国がんセンター（愛媛県）
九州大学病院（福岡県）
東京都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
7
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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020743
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
