UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030603 |
|---|---|
| Receipt number | R000034950 |
| Scientific Title | Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701) |
| Date of disclosure of the study information | 2018/01/04 |
| Last modified on | 2022/12/22 14:12:15 |
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Basic information
Public title
Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Acronym
Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Scientific Title
Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Scientific Title:Acronym
Phase II trial of docetaxel plus ramucirumab combination therapy in patients with advanced EGFR gene mutation positive advanced stage non-squamous cell nonsmall cell lung cancer (HSR 1701)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to verify the effectiveness and safety of combination chemotherapy with ramcilmab and docetaxel in patients with EGFR gene mutation positive nonsquamous non-small cell lung cancer with a history of treatment with EGFR-TKI and platinum combination chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression-free survival from the start of treatment
Key secondary outcomes
response rate, disease control rate, overall survival, safety
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 |
Interventions/Control_1
Docetaxel (60 mg / m 2, day 1) + Ramucirumab (10 mg/kg, day 1) and PEG-G-CSF(3.6 mg, day 2) every 3 weeks until progression or both docetaxel and rRamucirumab termination.
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) 20 years old or older.
2) Histologically or pathologically proven non-squamous NSCLC with EGFR mutation.
3) Cases with a history of treatment with EGFR-TKI and platinum combination therapy.
4) Presence of measurable lesions on RECIST ver.1.1.
5) Eastern Cooperative Oncology Group (ECOG) performance status: 0-2.
6) Stage 3B, 4, or recurrence, two weeks or more have passed since the completion of radiotherapy.
7) Life expectancy of more than 3 months.
8) Written informed.
9) major organs are held by the examination value within 30 days and clinical examination at the start of treatment meets the following criteria
Neut >= 1,500/mm3
Hb >= 9.0 g/dL
CRE <= 1.5 mg/dL
T-bil <= 1.5 mg/dL
AST/ALT <= 100 IU/L (<= 200 IU/L by liver metastases)
Protein uria <= 1+
Key exclusion criteria
1) Diagnosed as squamous cell carcinoma
2) History of hemoptysis(=>2.5mL)
3) Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
4) With thromboembolism
5) Peptic ulcer, gastrointestinal perforation, intestinal diverticulitis, inflammatory bowel disease combined
6) Tumor invasion in the blood vessel.
7) Symptomatic brain metastasis.
8) Exposure of the tumor to the central airway
9) With third-space fluid need to be drained.
10) Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included).
11) With severe complications
Intestinal palsy, intestinal obstruction
Interstitial pneumonia or pulmonary fibrosis
Superior vena cava syndrome
Difficult-to-control diabetes, hypertension, liver disorder, angina pectoris, congestive heart failure and myocardial infarction within 3 months after onset
Cases with complications of severe infection or cases suspected of severe infection
Cases with complications that are deemed to cause serious obstruction to treatment enforcement
12)Anticoaglation with aspirin (> 325 mg / day) or clopidogrel (> 75 mg / day). Prophylactic use of anticoagulants is acceptable).
13)Pregnant or breastfeeding women. Willing to get pregnant. Severe psychological disease
14)Judgment to attending physician.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Sakurai |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
053-435-2263
Homepage URL
sakushow@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu university school of medicine Research cooperation section research support staff
Address
Shizuoka Ken Hamamatsu city Handayama 1-20-1
Tel
053-435-2111
rinri@hama-med.ac.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
浜松医科大学 第二内科 (静岡県)
磐田市立総合病院 呼吸器内科(静岡県)
静岡県立総合病院 呼吸器内科 (静岡県)
JA静岡厚生連遠州病院 呼吸器内科 (静岡県)
静岡赤十字病院 呼吸器内科 (静岡県)
静岡市立静岡病院 呼吸器内科 (静岡県)
静岡市立清水病院 呼吸器内科 (静岡県)
聖隷三方原病院 呼吸器内科 (静岡県)
聖隷浜松病院 呼吸器内科 (静岡県)
独立行政法人国立医療機構 天竜病院 呼吸器・アレルギー科(静岡県)
浜松赤十字病院 呼吸器内科 (静岡県)
浜松労災病院 呼吸器内科 (静岡県)
浜松医療センター 呼吸器内科(静岡県)
藤枝市立総合病院 呼吸器内科(静岡県)
静岡済生会病院 呼吸器内科(静岡県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034950
