UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Title of the study (Brief title)	A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)
Region	Japan

Condition
Condition	Previously treated non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival, Overall survival, Frequency and grade of adverse event

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	Bevacizumab 15mg/kg (day1, 22) + S-1 80mg/m2 (day1~14) q3weeks until disease progression
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.Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer 2.Stage III/IV non-small cell lung cancer without any indications for radiotherapy 3.Measurable disease 4.Patients who have previously treated with one regimen 5.EGFR, ALK, and MET inhibitor mono-therapy or combination therapy does not mean previous chemotherapy regimen 6.Adjuvant chemotherapy and Neo-adjuvant chemotherapy is not included in a postoperative regimen / at least 180 days interval from the last dosage of adjuvant chemotherapy 7.Age 20=< 8.ECOG performance status of 0 to 2 9.Patiants who can take in drug orally 10.Adequate organ function, evaluated within 14 days before enrollment as; WBC >= 3,500 /mm3 Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL AST (GOT) , ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.5mg/dL SpO2 >= 90% or >= 60 torr 11.Expected to live over 12 weeks after administration days 12.Written informed consent from the patients.
Key exclusion criteria	1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Symptomatic brain metastasis 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3833
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3833
Homepage URL	http://www.med.osaka-u.ac.jp/pub/imed3/lab_8/clinical.html
Email	tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Dept. of Respiratory Medicine, Osaka University Hospital
Institute
Department

Funding Source
Organization	Dept. of Respiratory Medicine, Osaka University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2012 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 06 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 07 Month 15 Day
Date trial data considered complete	2016 Year 07 Month 15 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Thirty patients were enrolled. The RR was 6.7% (95%CI 1.8-21.3%), and the disease control rate was 80% (95%CI 62.7-90.5%). Median PFS was 4.8 months (95%CI 2.7-6.4 months), and median OS was 13.8 months (95%CI 8.4 months-not applicable). Patients did not experience any Grade 4 toxicity or treatment-related death. Grade 3 hematologic toxicity (anemia) occurred in one patient (3.3%). The main Grade 3 non-hematologic toxicities were anorexia (10%), infection (10%), and diarrhea (6.7%).
Other related information

Management information
Registered date	2012 Year 06 Month 13 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009603