UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Title of the study (Brief title)	A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of maintenance Bevacizumab+Erlotinib following Carboplatin+Pemetrexed+Bevacizumab with Non-squarmous Non-small-cell lung cancer not harboring EGFR mutations for patient
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival at 6 months
Key secondary outcomes	Response rate Shift ratio to maintenance therapy 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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pemetrexed+Carboplatin+Bevacizumab followed by maintenance Erlotinib+Bevacizumab 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Age: 20-74 years 2)Histologically or cytrologically confirmed diagnosis of non-squamous non-small cell lung cancer (non-squamous NSCLC). 3)Stage IIIB/IV or postoperative recurrence 4)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy. 5)Patients who have measurable lesions. 6)Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2. 7)Adequate function of main organ. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST,ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr (or SpO2>=95%) Proteinuria<1+ 8)Life expectancy more than 3 months 9)Written informed consent
Key exclusion criteria	1)Previous histories of drug allergy, which may increase the risk of this study. 2)Serious concomitant infection. 3)Usages of oral steroids or immunosuppressive drugs. 4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6)Patients with EGFR mutation. 7)Severe pleural, abdominal or cardiac effusion. 8)Prior to study entry major surgical procedures within 3 weeks or prior systemic therapy to contain radiotherapy within 2 weeks. 9)Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event. 10)No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg). 11)Symptomatic brain metastasis. 12)The patient that the tumor permeation to chest great vessels is accepted. 13)cavity in tumor. 14)receiving anticoagulant drug(except Aspirin under 325mg/day). 15)Patients with active concomitant malignancy. 16)Pregnant, lactating women. 17)Inappropriate patients judged by physicians.
Target sample size	51

Research contact person
Name of lead principal investigator	Satoshi Oizumi
Organization	Hokkaido University
Division name	First Department of Medicine
Address	North 15,West7, Kita-ku, Sapporo 060-8638, Japan
TEL	011-706-5911
Email	soizumi@med.hokudai.ac.jp

Public contact
Name of contact person	Noriyuki Yamada
Organization	Hokkaido University
Division name	First Department of Medicine
Address	North 15,West7, Kita-ku, Sapporo060-8638, Japan
TEL	011-706-5911
Homepage URL
Email	ymda3nr222@gmail.com

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

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)

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	2011 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 28 Day
Last modified on	2017 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006905