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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024438
Receipt No. R000028092
Scientific Title A Phase II, Open Label, Randomized Study of Osimertinib (TAgrisso) alone Versus Osimertinib plus Carboplatin/Pemetrexed for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose TUmours Harbour a T790M MutatIon Within the Epidermal Growth Factor Receptor Gene
Date of disclosure of the study information 2016/10/17
Last modified on 2017/10/17

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Basic information
Public title A Phase II, Open Label, Randomized Study of Osimertinib (TAgrisso) alone Versus Osimertinib plus Carboplatin/Pemetrexed for Patients
With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose TUmours Harbour a T790M MutatIon Within the Epidermal Growth Factor Receptor Gene
Acronym TAKUMI Trial
(LOGIK1604/NEJ032A)
Scientific Title A Phase II, Open Label, Randomized Study of Osimertinib (TAgrisso) alone Versus Osimertinib plus Carboplatin/Pemetrexed for Patients
With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose TUmours Harbour a T790M MutatIon Within the Epidermal Growth Factor Receptor Gene
Scientific Title:Acronym TAKUMI Trial
(LOGIK1604/NEJ032A)
Region
Japan

Condition
Condition T790M-positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of osimertinib with or without carboplatin and pemetrexed in patients with non-squamous non-small-cell lung cancer refractory to EGFR-TKI treatment and confirmed as T790M-positive by tumor specimens after exacerbation, and to explore whether the combination of the third generation EGFR-TKI and chemotherapy is the appropriate therapeutic strategy to be verified in a phase III study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression free survival
Key secondary outcomes response rate,
overall survival,
incidence of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: Osimertinib monotherapy
Consecutively administer oral dose of osimertinib at 80 mg/day every day at almost the same time for 3 weeks as one course, and continue treatment unless any of the discontinuation criteria of protocol treatment is applicable.

Interventions/Control_2 Group B: Combination therapy with osimertinib
1.Combination therapy with osimertinib/carboplatin/pemetrexed
Three weeks of the following regimen will consist of one course and 4 courses will be repeated unless discontinuation criteria for protocol treatment is applicable. Qsimertinib at 80 mg/day will be orally administered every day at almost the same time.
Carboplatin (AUC=5) wiil be administered at day 1 every 3 weeks course.
Pemeterexed at 500 mg/m2 will be administered at day 1 every 3 weeks course.
2. Combination maintenance therapy with osimertinib/pemetrexed in the case of CR, PR SD
Three weeks of the following regimen will consist of one course and continue unless discontinuation criteria for protocol treatment is applicable.
Qsimertinib at 80 mg/day will be orally administered every day at almost the same time.
Pemeterexed at 500 mg/m2 will be administered at day 1 every 3 weeks course.
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) Clinical stage IIIB or IV or postoperative recurrent non-squamous non-small cell lung cancer harbouring susceptible EGFR mutations (G719X mutation, exon 19 deletion, L858R mutation, L861Q mutation) that cannot be treated with curative radiotherapy
2) Aggravation confirmed by imaging diagnosis after treatment with the first- and second-generation EGFR-TKI and T790M mutation confirmed in tumor tissue specimens or blood specimen after exacerbation
3) No history of treatment with cytotoxic drugs. However, the patients who received the final dose more than one year prior to enrollment are eligible in case of recurrence after pre-or postoperative adjuvant chemotherapy.
4) At least 8 days passed after the final dose of EGFR-TKI.
5) Aged 20 years or older at the time of informed consent
6) ECOG performance status (PS): 0 or 1
7) No palliative radiotherapy for metastatic lesion(s) (including gamma knife therapy for brain metastasis within 7 days) within 14 days before enrollment
8) No Grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites
9) Irrespective of measurable lesion
10) All of the following criteria are met based on the laboratory data at the start of treatment (The data obtained within 14 days of enrollment: the same day of the week 2 weeks before enrollment is allowed):
1.WBC count:>=3000 /mm3
2.Neutrophil count:>=1500 /mm3
3.Hemoglobin:>= 9.0 g/dL (no blood transfusion within 14 days of screening)
4.Platelet count:>=10X10,000/mm3
5.AST:=< 100 IU/L
6.ALT:=< 100 IU/L
7.Total bilirubin:=< 1.5 mg/dL
8.SpO2:>=92 % (room air). Patients with SpO2 <92% are eligible if PaO2 is >=60 torr.
9.Creatinine:=<1.2 mg/dL
10. Creatinine clearance >=45 mL/min However, Ccr shall not exceed 120 (ml/min).
11)Have given written consent to participate in the study after receiving detailed explanation of the study
Key exclusion criteria 1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer).
2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan /Radiation pneumonitis which required steroid treatment
3) Not able to swallow oral medications
4) Previous treatment history of immune checkpoint inhibitors
5) Infection requiring systemic treatment
6) Fever of >=38(axillary temperature) at the time of enrollment
7) Psychosis or psychotic symptoms that may interfere with the patient's participation in the study
8) Symptomatic brain metastasis (clinically stable brain metastasis is eligible)
9) Adverse event of >=Grade 2 considered attributable to EGFR-TKI of the prior therapy
10) Receiving continuous systemic (oral or intravenous) immunosuppressant therapy
11) Complication of diabetes mellitus treated with continued use of insulin or poorly controlled diabetes mellitus
12) Complication of unstable angina (new-onset angina or exacerbation of angina within the last 3 weeks) or history of myocardial infarction within 6 months.
13) HBs antigen-positive
14) Pregnant or possibly pregnant women, lactating women, or patients who wish to become pregnant
15) Patients who, in the opinion of the attending physician, are inappropriate for the study
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name (1) Isamu Okamoto,(2) Satoshi Oizumi
Organization (1) Kyushu University,(2) National Hospital Organization Hokkaido Cancer Center
Division name (1) Research Institute for Diseases of the Chest,(2) Department of Respiratory Medicine
Zip code
Address (1) 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan,(2) 2-3-54, Kikusui4jo, Shiroishi-ku, Sapporo 003-0804, Japan
TEL 092-642-5378
Email okamotoi@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name (1) Kentaro Tanak,(2) Hajime Asahina
Organization (1) Kyushu University,(2) Hokkaido University School of Medicine
Division name (1) Research Institute for Diseases of the Chest,(2) First Department of Medicine
Zip code
Address (1) 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan,(2) Nishi 7 Cho-me, Kita15jo, Kita-ku, Sappo
TEL 092-642-5378
Homepage URL
Email tanaka-k@med.kyushu-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu (LOGIK)/North East Japan Study Group(NEJSG)
Institute
Department

Funding Source
Organization AstraZenaca
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 17 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
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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 09 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
2016 Year 10 Month 17 Day
Last modified on
2017 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028092

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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