Unique ID issued by UMIN | UMIN000003394 |
---|---|
Receipt number | R000004080 |
Scientific Title | Phase 2 study of Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation (CJLSG0907) |
Date of disclosure of the study information | 2010/03/29 |
Last modified on | 2019/03/31 05:44:21 |
Phase 2 study of Pemetrexed + Carboplatin as first line therapy
for non-squamous non-small cell lung cancer with EGFR Mutation (CJLSG0907)
Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation
Phase 2 study of Pemetrexed + Carboplatin as first line therapy
for non-squamous non-small cell lung cancer with EGFR Mutation (CJLSG0907)
Pemetrexed + Carboplatin as first line therapy for non-squamous non-small cell lung cancer with EGFR Mutation
Japan |
Advanced non-squamous non-small cell lung cancer with EGFR Mutation
Pneumology |
Malignancy
YES
To evaluate the efficacy and safety of combination therapy with pemetrexed and carboplatin for non-squamous non small cell lung cancer patients with epidermal growth factor receptor mutation.
Safety,Efficacy
Exploratory
Pragmatic
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 |
Pemetrexed 500mg/m2 day1 + Carboplatin AUC6 day1, q3w, 3-6 cycles
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Histologically or cytologically proven non-squamous non small cell lung cancer
2) Patients having EGFR mutation (exon 19 deletion or L858R)
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) Active infection
2) Fever
3) Serious disease condition
4) Active double cancer
5) Symptomatic brain metastasis
6) Cavity fluid retention difficult to control
7) Severe drug allergy
8) Pregnancy or lactation
9) EGFR mutation (exon 20)
10) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
23
1st name | Hiroyuki |
Middle name | |
Last name | Taniguchi |
Tosei General Hospital
Respiratory medicine and allergy
4898642
160 Nishi-oiwake-cho, Seto, Aichi, Japan
0561-82-5101
taniguchi@tosei.or.jp
1st name | Tomoki |
Middle name | |
Last name | Kimura |
Tosei General Hospital
Respiratory medicine and allergy
4898642
160 Nishi-oiwake-cho, Seto, Aichi, Japan
0561-82-5101
lung@tosei.or.jp
Central Japan Lung Study Group
none
Self funding
Tosei General Hospital IRB
160 Nishi-oiwakecho, Seto, Aichi
0561-82-5101
ychikenn@tosei.or.jp
NO
2010 | Year | 03 | Month | 29 | Day |
Unpublished
Main results already published
2010 | Year | 01 | Month | 30 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2010 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004080