Unique ID issued by UMIN | UMIN000003736 |
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Receipt number | R000004511 |
Scientific Title | Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909) |
Date of disclosure of the study information | 2010/06/11 |
Last modified on | 2019/03/31 05:47:21 |
Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909)
Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation
Phase 2 study of Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation (CJLSG0909)
Pemetrexed + Carboplatin + Bevacizumab as first line therapy for nonsquamous non-small cell lung cancer without EGFR Mutation
Japan |
Advanced non-squamous non-small cell lung cancer without EGFR Mutation
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of combination therapy with pemetrexed, carboplatin and bevacizumab for non-squamous non small cell lung cancer patients without epidermal growth factor receptor mutation.
Safety,Efficacy
Phase II
Response rate
Adverse events
Disease control rate
Overall survival
Progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients receive Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1 + Bevacizumab 15mg/kg day1, q3w, 4-6 cycles.
Patients who achieved disease control receive Pemetrexed 500mg/m2 day1 + Bevacizumab 15mg/kg day1, q3w until disease progression.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Histologically or cytologically proven non-squamous non small cell lung cancer
2) Patients with EGFR wild type
3) Patients with stage IIIB or IV, or recurrent disease after surgery and was not a candidate for curative radiotherapy
4) No prior chemotherapy
5) Patient who has measurable lesion by RECIST
6) Age: 20-74
7) ECOG PS: 0-1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent
1) Brain metastasis
2) Hemoptysis (>=2.5ml)
3) Active infection
4) Fever
5) Serious disease condition
6) Active double cancer
7) Cavity fluid retention difficult to control
8) Severe drug allergy
9) Receiving anticoagulant drug (except Aspirin under 325mg/day)
10) Active GI bleeding or inflammation in the abdominal cavity.
11) Pregnancy or lactation
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
52
1st name | |
Middle name | |
Last name | Hiroyuki Taniguchi |
Tosei General Hospital
Respiratory medicine and allergy
160 Nishi-oiwake-cho, Seto, Aichi, Japan
0561-82-5101
lung@tosei.or.jp
1st name | |
Middle name | |
Last name | Tomoki Kimura |
Tosei General Hospital
Respiratory medicine and allergy
160 Nishi-oiwake-cho, Seto, Aichi, Japan
0561-82-5101
lung@tosei.or.jp
Central Japan Lung Study Group
Central Japan Lung Study Group
Other
NO
2010 | Year | 06 | Month | 11 | Day |
Unpublished
Main results already published
2010 | Year | 05 | Month | 06 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2015 | Year | 04 | Month | 30 | Day |
2010 | Year | 06 | Month | 11 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004511
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