UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015467 |
|---|---|
| Receipt number | R000017967 |
| Scientific Title | Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-squamous, non-small cell lung cancer harboring activating EGFR mutations |
| Date of disclosure of the study information | 2014/10/18 |
| Last modified on | 2018/10/21 20:57:18 |
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Basic information
Public title
Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-squamous, non-small cell lung cancer harboring activating EGFR mutations
Acronym
Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-small cell lung cancer harboring activating EGFR mutations
Scientific Title
Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-squamous, non-small cell lung cancer harboring activating EGFR mutations
Scientific Title:Acronym
Phase II study of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-small cell lung cancer harboring activating EGFR mutations
Region
| Japan |
Condition
Condition
advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of the treatment of erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment for advanced non-squamous, non-small cell lung cancer harboring activating EGFR mutations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
Overall survival, objective response rate, toxity, QOL,Exploratory purpose: using the next-generation sequencer, we examine the therapeutic effect over time and changes in circulating free DNA of EGFR gene mutations from plasma.
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
erlotinib plus bevacizumab and inserted cisplatin, pemetrexed plus bevacizumab as a 1st-line treatment
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Cytologically or histologically documented non-squamous non-small cell carcinoma of the lung
2) Harboring activating EGFR mutation (exon 19 deletion, and / or exon 21 L858R point mutation)or uncommon mutation (G719X or L861Q).
3) Have NSCLC with Stage IIIB, not candidate for curative radiotherapy, Stage IV or recurrence disease after surgery
4)No previous chemotherapy. If preoperative or postoperative adjuvant chemotherapy was done, it has passed more than six months from the last day of administration.
5)All of the following conditions is necessary if a patient has previously received radiation therapy.
1.Extra pulmonary fied
2.More than 12 weeks since prior radiotherapy to thoracic bones.
3.More than 2 weeks since prior radiotherapy to extra-thoracic sites.
6)If there is evaluable lesions or without measurable lesions.
7))>=20 and <=74 years of age.
8)ECOG performance status of 0 or 1.
9)Adequate organ function.
10)Written informed consent.
11)Expected survival of >= 3 months.
Key exclusion criteria
1)Harboring EGFR mutation of Exon20,T790M
2)Have symptomatic brain metastases or spinal metastases requiring surgical treatment or irradiation.
3)The presence of other concomitant malignancy less than 5 years disease-free interval
4)Have a pleural effusion, ascites or pericardial effusion requiring treatment
5)SVC syndrome
6)Symptomatic spinal cord compression
7)Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment
8)Have sn unhealed fracture
9)Have a serious concomitant active infection
10)Have any evidence of interstitial lung on chest X-ray
11)Have a serious unstable angina, congestive heart failure, arrythmia requiring treatment and a history of myocardial infarction within 12 months prior to enrollment.
12)Clinically significant drug allergy
13)History of use of pemetrexed or EGFR-TKI as preoperative or postoperative adjuvant therapy
14)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception
15) Mental disease or psychotic manifestation
16)Not suitable for participating in the study for any other reason
17)Currently have or have a history of hemoptysis
18) Patients with or with anticipation of invasive procedures as defined below:
1.Major surgery within four weeks of registration
2.two weeks after drainage tube removal
3.two weeks after pleurodesis
4.Minor surgical procedures or core biopsy within two weeks of registration etc.
19)Have a bleeding tendency
20)Have an intestinal diverticulitis
21)Have a history of gastrointestinal perforation less than one year prior to enrollment
22)Uncontrolable hypertension
23)Have a evidence of thrombosis
24)HBs antigen-positive cases
Others
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka
TEL
0669711181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Nishino |
Organization
Osaka Medical Center for Cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka
TEL
0669721181
Homepage URL
nisino-ka@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Thoracic Oncology
Osaka Medical Center for Cardiovascular diseases
Institute
Department
Personal name
Funding Source
Organization
no
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
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
大阪府立成人病センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017967
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