louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01834807: A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis
Official title: Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-04-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who are currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Brief summary: This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra \[tocilizumab\]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis
* Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Exclusion Criteria:

* Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
* Patients that have started their current monotherapy before 01/01/2009

Primary outcomes:
measure: Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice
timeFrame: approximately 1 year
measure: Type of biological agents used in monotherapy in routine clinical practice
timeFrame: approximately 1 year
Secondary outcomes:
measure: Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores
timeFrame: approximately 1 year
measure: Quality of life: HAQ-DI score
timeFrame: approximately 1 year
measure: Safety of biologics used in monotherapy: Incidence of adverse events
timeFrame: approximately 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Kortrijk
country: Belgium
city: Liège
country: Belgium
city: Merksem
country: Belgium
city: Mons
country: Belgium
city: Seraing
country: Belgium
city: Turnhout
country: Belgium
city: Verviers
country: Belgium
city: Westmalle
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00897507: DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
Official title: Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Acute Lymphoblastic Leukemia in Remission
Recurrent Childhood Acute Lymphoblastic Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 520
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment

Detailed description: PRIMARY OBJECTIVE:

I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.

II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.

III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.

IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.

OUTLINE:

Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X\^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.

Eligibility criteria: Inclusion Criteria:

* Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL

Primary outcomes:
measure: Leukemia Relapse
timeFrame: Day 7
measure: Development of veno-occlusive disease in patients on CCG-1952
timeFrame: Day 28
measure: Development of a predictive model of leukemia relapse
timeFrame: Day 28
measure: Development of a predictive model of leukemia toxicity
timeFrame: Day 28
Secondary outcomes:
measure: Development of grade III/IV toxicity as defined by the CCG toxicity criteria
timeFrame: Day 28
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Richard Aplenc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06482307: Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
Official title: Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients with HNSCC
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \[18F\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.


Eligibility criteria: Inclusion Criteria:

1. Patients \>18y, with biopsy-proven HPV-negative HNSCC, or patients \>40y with HPV-positive HNSCC and high-risk features (i.e. \> 10 smoke packs/year AND ≥N2b)
2. Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
3. Recent archival tumour tissue (\<8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels
4. Presence of a tumour lesion ≥10 mm in diameter
5. ECOG performance status 0-2
6. Negative pregnancy test in women with childbearing potential
7. Life expectancy \>3 months
8. Signed written informed consent and able to comply with the protocol
9. For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)

Exclusion Criteria:

1. Recent treatment with PARP inhibitors or other investigational therapies \<30 days.
2. Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.

Primary outcomes:
measure: Dosimetry assessment
timeFrame: 6-12 months
measure: Correlation between tumour uptake and expression
timeFrame: 12-18 months
Secondary outcomes:
measure: Evaluation of changes in tumour uptake
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Michel van Kruchten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459207: Association Between Body Composition and Pain in Spinal Cord Injury
Official title: Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Inflammatory Response
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* SCI occurring at least 2 years prior to study entry
* Neurological level of injury (LOI) between C4 and L2
* American Spinal Injury Association Impairment Scale (AIS) A-D
* English-speaking.

Exclusion Criteria:

* Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
* Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury \> Stage 2)
* Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture \> 15 degrees)
* Inability to obtain free-flowing blood from a superficial forearm or hand vein
* Pregnant women
* Prisoners

Primary outcomes:
measure: peak change in Interleukin (IL)-6
timeFrame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
measure: peak change in evoked pain sensitivity
timeFrame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Secondary outcomes:
measure: correlation coefficient between changes in IL-6 and evoked pain sensitivity
timeFrame: at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth Felix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932107: Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection(QLG2174) in the Prevention of Post-operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 70 years, with a body mass index (BMI) of 18-30 kg/m² and body weight≥45kg.
* laparoscopic gynecologic or abdominal surgery under general anesthesia (duration≥1 hour and postoperative hospitalization ≥24 hours), with anesthesia maintained using sevoflurane and remifentanil (propofol maintenance was prohibited);
* had≥2 risk factors of PONV; expected to use postoperative opioid within 24 hours after surgery;
* American Society of Anesthesiologists (ASA) physical status class I-III.

Exclusion Criteria:

* planned intrathoracic, transplant, or central nervous system surgeries;
* diagnostic-only procedures;
* use of local/regional anesthesia (e.g., neuraxial/nerve blocks);
* postoperative intensive care unit (ICU) transfer;
* preoperative nasogastric/orogastric tube placement (from screening through 24 hours postoperatively)
* nausea, vomiting, retching, or organic disease-related emesis (e.g., intestinal obstruction) within 24 hours preoperatively; history of malignancy, epilepsy, or vestibular dysfunction;
* hypersensitivity to aprepitant;
* recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, corticosteroids; within 1 week), strong CYP3A4 inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
* clinically significant laboratory abnormalities (ALT/AST ≥2×upper limit of normal \[ULN\], total bilirubin ≥1.5×ULN, creatinine ≥1.5×ULN, hemoglobin ≤90 g/L)

Primary outcomes:
measure: Complete response (CR) rates over 24 hours after the end of surgery
timeFrame: 0-24 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Study officials:
References:
Clinical trial NCT01196507: Early Primary Prophylaxis of Esophageal Varices
Official title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score\& adverse events.


Eligibility criteria: Inclusion Criteria:

- Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Any EVL or sclerotherapy within last 3 months
* Child Turcotte Pugh (CTP) score \> 12, refractory ascites, hepatorenal syndrome
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy that affects survival.
* Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
* Past history of surgery for portal hypertension
* Uncontrolled diabetes
* Peripheral vascular disease
* Refusal to participate in the study

Primary outcomes:
measure: The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group.
timeFrame: 2 Years
Secondary outcomes:
measure: Survival
timeFrame: 2 Years
measure: adverse effects of drugs
timeFrame: 2 Years
measure: reduction in HVPG
timeFrame: 1 Year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences (ILBS)
name: Shiv Kumar Sarin, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
Clinical trial NCT00048607: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)
Official title: A Double-Blind, Multicenter, Placebo and Active-Controlled, Acute Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-11-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: HAMD-17 total score at week 8. Tolerability.
timeFrame: at week 8
Secondary outcomes:
measure: CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8
timeFrame: at week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.
citation: Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
Clinical trial NCT02916407: The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
Official title: The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Entropion
Keywords: Anesthesia
Agitation
Extubation
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

Detailed description: This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologist class 1 patients
* 3-6 years children undergoing entropion surgery

Exclusion Criteria:

* Do not agree with participate this study

Primary outcomes:
measure: Extubation Time
timeFrame: 30 minutes
Secondary outcomes:
measure: Degree of Postoperative Agitation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae paik hospital, inje university
Study officials:
affiliation: Inje University
name: Ki Hwa Lee, M.D,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03644407: Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring
Official title: Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Spine Surgery
Scoliosis
Disc Disease
Disc Injury
Myelopathy
Spinal Stenosis
SPINAL Fracture
Spinal Fusion
Keywords: registry
scoliosis
disc disease
spinal fracture
spinal fusion
spine surgery
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 10000
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo spine surgery in the participating centers and give informed consent to participate

Brief summary: The SPINEREG study is a prospective observational registry. Eligible patients are subjects undergoing spine surgery at the participating institutions.

Baseline health status and follow-up health status are recorded at pre-established steps.

Detailed description: The SPINEREG study is a prospective observational study. Eligible patients are subjects undergoing spine surgery at the participating institutions.

Baseline health status and follow-up health status are recorded at pre-established steps.

Data from surgery and patients PROMs are registered on the database; the main timepoints are: pre-surgery, surgery, 3-6 month after surgery, 1-2-5-10-15-20 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing spine surgery in the participating centers

Exclusion Criteria:

* Patients only in conservative treatment
* Patients to refuse to enter the study

Primary outcomes:
measure: Spinal function (Oswestry Disability Index score)
timeFrame: 1 years
measure: Reliability of the data collected in SpineReg
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT01784107: A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Official title: A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Keywords: SCLC
belotecan
Ifosfamide
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.

Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed extensive disease of Small cell lung cancer
* no prior chemotherapy or radiotherapy for lung
* measurable lesion for RECIST
* over 18 years
* ECOG 0\~2
* expected life span more than 3 months

Exclusion Criteria:

* acute or active infection
* uncontrolled cerebral nerve symptoms or metastasis
* significant myocardial infarction or cardiac disease within 12 months

Primary outcomes:
measure: MTD (maximal tolerated dose)
timeFrame: one year
Secondary outcomes:
measure: DLT(dose-limiting toxicity)
timeFrame: one year
Other outcomes:
measure: Response rate
timeFrame: one year
measure: PFS(Progression-Free-Survival)
timeFrame: one year
measure: Overall Survival
timeFrame: one year
measure: Number of participants with adverse events
timeFrame: one year
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References: