UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Serum marker analysis of Erlotinib treatment in previously treated Non-small cell lung cancer (NSCLC) patients with and without Epidermal Growth Factor Receptor (EGFR) mutation (additional study of CJLSG0903/0904)
Title of the study (Brief title)	Serum marker analysis of Erlotinib treatment in previously treated NSCLC patients with and without EGFR mutation
Region	Japan

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

Objectives
Narrative objectives1	To investigate the correlation between the serum marker analysis and the efficacy of Erlotinib treatment for previously treated NSCLC patients with and without EGFR Mutation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate the correlation between the serum marker analysis and the clinical data such as response rate, disease control rate, overall survival and progression free survival for previously treated NSCLC patients with and without EGFR Mutation.
Key secondary outcomes	To acquire the additional information on possible correlation between serum marker analysis and EGFR mutation status in previously treated NSCLC patients.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients with pathologically proven non-small cell lung cancer. 2) Patients who are not candidates for curative radiotherapy. 3) Patients with EGFR wild type or EGFR mutation (exon 19 deletion or exon 21 L858R) *Gene analysis by PNA-LNA PCR clamp method 4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.). 5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen). 6) Patient who has at least one or more measurable lesion by RECIST. 7) ECOG performance status (PS): 0-2 8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it. 9) Patients aged 20 years or older. 10) Adequate organ function. 11) Patients who are considered to survive for more than 3 months. 12) Written informed consent.
Key exclusion criteria	1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease,Unstable angina,Cardiac infarction, Psychological illness, etc.). 2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease,pneumoconiosis,active radiation pneumonia,etc.). 3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome. 4) Symptomatic brain metastasis. 5) Severe drug allergy. 6) Previous radiotherapy to primary lung cancer. 7) Patients who have previously treated three or more chemotherapy. 8) Patients who had a relapse after surgery. 9) With active double cancer. 10) Pregnancy or lactation. 11) Severe disorder of the eye. 12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size	83

Research contact person
Name of lead principal investigator	Yoshinori Hasegawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	65 Tsurumaicho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan
TEL
Email

Public contact
Name of contact person	Masashi Kondo, Masahiro Morisse, Tetsunari Hase
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	cjlsg@med.nagoya-u.ac.jp
TEL
Homepage URL
Email

Sponsor
Institute	Central Japan Lung Study Group (CJLSG)
Institute
Department

Funding Source
Organization	Central Japan Lung Study Group (CJLSG)
Organization
Division
Category of Funding Organization	Other
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 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 13 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	Unpublished
URL releasing results
Results
Other related information	Additional study of CJLSG0903/0904. Blood draw before Erlotinib treatment.

Management information
Registered date	2011 Year 06 Month 10 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006802