Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Mitogens

This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.

At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Retrospective Study in a NSCLC M+ p

Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain

AstraZeneca

Rare Diseases

Lung Diseases, Interstitial

Respiration Disorders

Chronic Graft Versus Host Disease

Yong Chul Lee, MD, phD

Yong Chul Lee, MD, PhD

So Ri Kim, MD, PhD

Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary disorders

Measurement:

1. Unfolded protein responses (UPRs) in blood (PBMCs)of patients

   1. CHOP
   2. GRP 78 and so on
2. Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls

   1. CHOP
   2. GRP 78 and so on

Endoplasmic Reticulum Stress in Chronic Respiratory Diseases

Endoplasmic Reticulum (ER) Stress in Patients With Various Chronic Pulmonary Diseases

Chonbuk National University

Yong Chul Lee

Antineoplastic Agents

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Imatinib Mesylate

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Imatinib mesylate

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6

Julie Bauman, MD

This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.

Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.

Overall survival as measured by the Kaplan-Meier method

Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)

Adverse events of grade 3 or higher, according to CTCAE version 3

Fred Hutchinson Cancer Center

Novartis

New Mexico Cancer Care Alliance

Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Imatinib Mesylate and Paclitaxel

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Julie E. Bauman, MD

6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.

Response Rate

Overall Survival

Progression Free Survival

All enrolled and treated patients were evaluated for grade 3 or higher toxicities.

Toxicities

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

CLR457

Novartis Pharmaceuticals

To estimate the maximum tolerated dose (MTD) or recommended dose for phase II (RP2D) of CLR457 and to investigate the anti-tumor activity of CLR457

Phase ll part of the study was not conducted as Novartis decided to terminate the study considering safety and tolerability concerns and limited clinical activity.

Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies

A Phase I/II Multicenter, Open-label Study of CLR457, Administered Orally in Adult Patients With Advanced Solid Malignancies

Parameters including but not limited to Cmax, Cmin, AUCinf, AUCtlast, AUCtau and T1/2

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Mediastinal Neoplasms

Sarcoidosis

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

Mediastinal Diseases

Thoracic Diseases

Lymphosarcoma

virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session

virtual bronchoscopy guided transbronchial needle aspiration

endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions

endobronchial ultrasound guided transbronchial needle aspiration

Rafal Krenke, MD, PhD

Piotr Korczynski, MD, PhD

Renata Langfort, MD, PhD

Joanna Domagala-Kulawik, MD, PhD

The study has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. The software uses data from thorax CT scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. The most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in VB mode.

The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.

Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling

Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.

Number of patients in whom large mediastinal vessels would be injured when performing VB-TBNA will be compared with respective number of patients with EBUS-TBNA associated large vessel injury.

Comparison of the quality and adequacy of the cytologic specimens (in terms of lymphocyte percentage, the presence of neoplastic cells and dust-laden macrophages) collected by VB-TBNA vs. EBUS-TBNA in patients with mediastinal mass or mediastinal lymph node enlargement

Comparison of the diagnostic accuracy of VB-TBNA vs. EBUS-TBNA (in terms of number of cytologic specimens containing diagnostic material e.g. neoplastic cells, granulomas) in patients with mediastinal mass or mediastinal lymph node enlargement. Also the number of patients in whom the specific diagnosis could be established by VB-TBNA vs EBUS-TBNA.

Warsaw University of Technology

Medical University of Warsaw

MD, PhD

Fluorides

Fluorodeoxyglucose F18

alpha-Methyltyrosine

L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid transporter 1 (LAT1).

Evaluation of Thoracic Tumors With 18F-FMT and 18F-FDG PET-CT A Clinicopathological Study

Evaluation of Thoracic Tumors With 18F-FMT and 8F-FDG PET-CT: A Clinicopathological Study

J~pharma

Gunma University

Neuroendocrine Tumors

Carcinoma, Large Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Carboplatin

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.

Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.

RAD001

Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.

Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cancer With Neuroendocrine Differentiation (LC-NEC)

Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.

DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.

OS was defined as the time from date of start of treatment to date of death due to any cause.

RAD001 Plus Paclitaxel/Carboplatin

Study Director

All participants were included in the analysis.

Percentage of Participants Progression-free

Percentage of Participants With Overall Response Rate (ORR)

Percentage of Participants With Disease Control Rate (DCR)

Progression Free Survival (PFS)

Overall Survival (OS)

kyoichi kaira, MD

Objective: L-\[3-18F\]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino acid transporter 1 (LAT1) expression also investigated.

Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retrospective Study in a NSCLC M+ p	NCT01795352	EGFR Mutated No...		18 Years -	AstraZeneca
Endoplasmic Reticulum Stress in Chronic Respiratory Diseases	NCT01211015	ER Stress, Chronic Airway ... Lung Cancer, Interstitial Lu...		18 Years - 80 Years	Chonbuk National University
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer	NCT01011075	Non-small Cell ...	Imatinib mesyla... Paclitaxel	70 Years -	New Mexico Cancer Care Alliance
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer	NCT01011075	Non-small Cell ...	Imatinib mesyla... Paclitaxel	70 Years -	New Mexico Cancer Care Alliance
Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies	NCT02189174	Advanced Solid ...	CLR457	18 Years -	Novartis
Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling	NCT01784185	Lung Cancer, Mediastinal Tum... Lymphomas, Sarcoidosis,	virtual broncho... endobronchial u...	18 Years -	Medical University of Warsaw
Evaluation of Thoracic Tumors With 18F-FMT and 18F-FDG PET-CT A Clinicopathological Study	NCT00698373	Non-Small Cell ...		20 Years -	Gunma University
RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation	NCT01317615	Carcinoma, Larg... Neuroendocrine ...	RAD001 Paclitaxel Carboplatin	18 Years -	Novartis
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer	NCT01011075	Non-small Cell ...	Imatinib mesyla... Paclitaxel	70 Years -	New Mexico Cancer Care Alliance
Fluorine-18-α-Methyltyrosine Positron Emission Tomography for Diagnosis and Staging of Lung Cancer	NCT00464282	Carcinoma, Non-...		8 Months - 2 Years	Gunma University

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