University of Vermont

The University of Vermont Cancer Center

trials_lung

Lung Cancer Clinical Trials

The University of Vermont Cancer Center has many trials specifically focused on lung cancer research.

Status: Active - Recruiting
Study Title: Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Purpose: The purpose of this study is to compare any good and bad effects of using the anti-diabetic drug, metformin, along with the standard of care radiation therapy and chemotherapy to using the standard of care radiation therapy and chemotherapy alone. In the last decade, several scientific studies have shown that the use of metformin is associated with a decreased incidence of cancer. Furthermore, metformin use has been associated with improved outcomes when used with radiation and/or chemotherapy. The addition of metformin to the usual radiation and chemotherapy may shrink your cancer more than the usual radiation and chemotherapy alone and help prevent it from returning, but it could also be of no benefit. Additionally it may cause side effects. This study will allow the researchers to know whether adding metformin to radiation and chemotherapy is better, the same, or worse than radiation and chemotherapy alone. To be better, adding metformin should increase by 10 patients in 100 the ability of radiation and chemotherapy to prevent lung cancer from returning in 1 year compared to the standard of care. Metformin is already FDA-approved for use in diabetes, and studies have shown that it is generally safe for use in non-diabetic patients.
ClinicalTrials.gov Identifier: NCT02186847
Primary/Site/Co Investigator: Christopher Anker, MD
Contact: Alexandra Albertson (802) 656-2178
Information: http://clinicaltrials.gov/ct2/results?term=LU-001&Search=Search
Institution Number: N/A
Protocol Research Type: Cooperative Group
Status: Active - Recruiting
Study Title: A Phase III, Double-Blind, Randomized Study to Assess the Efficacy and Safety of AZD9291 versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Purpose: The purpose of this study is to compare AZD9291 with erlotinib in patients with EGFR mutated lung cancer who have not yet received any drug therapy for their locally or metastatic lung cancer. Comparing these two treatments will help to determine whether AZD9291 is more, less or equally effective than standard therapy in extending the time before your lung cancer gets worse. In order to be eligible for the study, your tumor must be confirmed to have an EGFR mutation.
ClinicalTrials.gov Identifier: NCT02296125
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02296125?term=FLAURA&rank=1
Institution Number: 15-426
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: CALGB-140503:A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
Purpose: The purpose of this study is to test a different way of doing surgery for lung cancer in patients who have small tumors with no evidence of spread. Recent studies have questioned whether removing a larger portion of the lung containing the tumor offers better control of the cancer than removing a smaller section of the lung. The purpose of this clinical trial is to look at whether removal of a small section of lung (called a sublobar resection) is equal to a lobectomy (a larger surgery which takes out an entire section or ‘lobe’ of the lung, or about one-quarter to one-half of one lung, depending on which lobe is taken out). This clinical trial will be studying the overall effects (good and/or bad) of a sublobar resection (smaller segment of your lung) compared to a lobectomy (entire lobe of your lung).

 

ClinicalTrials.gov Identifier: NCT00499330
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT00499330
Institution Number: CALGB-140503
Protocol Research Type: Cooperative Group
Status: Active - Recruiting
Study Title: Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer
Purpose: The purpose of this study screening step is to test specific genes and proteins in your tumor sample. Based on the test results, you will be assigned to one of the treatment studies. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor. You may choose to not take part in the treatment study assigned to you. Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in treatment on this research study.

 

ClinicalTrials.gov Identifier: NCT02154490
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02154490?term=s1400&rank=1
Institution Number: SWOG 1400
Protocol Research Type: Cooperative Group
Status: Active - Recruiting
Study Title: JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients with Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy
Purpose: The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.
ClinicalTrials.gov Identifier: NCT02152631
Primary/Site/Co Investigator: Bruce J Leavitt, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02152631?term=JPBK&rank=1
Institution Number: 15-021
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: c-Jun N Terminal Kinase EMT and Lung Cancer
Purpose: The purpose of the study is to identify the role of c-Jun-N-terminal kinase-1 (JNK1) in epithelial to mesenchymal transition, and the role that JNK1 plays in this setting in the development of lung cancer. This study incorporates the use of human lung cancer specimens with KRas mutations, and JNK1 gene ablation studies in a K-Ras lung cancer model in the mouse.
ClinicalTrials.gov Identifier: N/A
Primary/Site/Co Investigator: Yvonne Janssen-Heininger, PhD
Contact: Yvonne Janssen-Heininger, PhD (802) 656-0995
Information: N/A
Institution Number: M11-210, VCC Lab 1100; Juckett Awardee
Protocol Research Type: Investigator Initiated
Status: Active - Recruiting
Study Title: A151216 – Genetic Testing for Patient with Resectable or Resected Lung Cancer
Purpose: The management of advanced lung cancer has been transformed based on tumor genetic testing. Tumor tissue is analyzed to identify genetic changes of epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements.  EGFR and ALK are both proteins found on the surface of cells and these genetic changes indicate sensitivity to treatment with tyrosine kinase inhibitors such as erlotinib and crizotinib.  

This current study, A151216 (ALCHEMIST), lays the groundwork for applying genetic testing directed therapies to resected lung cancer to determine whether therapy with tyrosine kinase inhibitors can improve cure rates in earlier stage disease.   The ALCHEMIST trial will screen patients with resected non-small cell lung cancer for EGFR mutations and ALK rearrangements  in a centralized CLIA-certified laboratory using resources from the NCI to facilitate accrual to randomized adjuvant studies.   Centralized testing will also minimize technical inconsistencies, provide access to genetic testing and allow additional genetic testing to be performed over time to study other subtypes of the disease. 

Patients who participate in this study will undergo collection of blood and tissue samples for centralized genetic testing of EGFR and ALK.  Patients who have had surgery prior to pre-registration will submit samples from the previous surgery for testing.  Based on the result of this centralized testing, participation in a treatment trial may be offered.    There are two additional treatment studies randomizing this specific lung cancer population to treatment with targeted therapy:

A081105:  A Randomized Double-Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer;  or

E4512 A Double-Blind  Trial of Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinb versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein. 

If the tumor does not have either of these genetic changes present, standard of care treatment will be offered, however, the patient will be followed for 5 years as part of this study.

A secondary objective of this study is to characterize the natural history of EFGR and ALK wild-type lung cancers to allow subsequent development of targeted therapies in the adjuvant and recurrent settings.
ClinicalTrials.gov Identifier: NCT02194738
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02194738?term=4512&rank=1
Protocol Research Type: Cooperative Group
Status: Active - Recruiting
Study Title: Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Purpose: This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in subjects with advanced or metastatic squamous NSCLC.
ClinicalTrials.gov Identifier: NCT02106546
Contact: Alexandra Albertson (802) 656-2178
Information: http://www.clinicaltrials.gov/ct2/show/NCT02106546?term=abbvie+m11-089&rank=1
Institution Number: CHRMS 15-004
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: A081105 - Randomized Double-Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non Small Cell Lung Cancer (NSCLC)
Purpose: This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
ClinicalTrials.gov Identifier: NCT02193282
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02193282?term=A081105&rank=2
Institution Number: 15-156
Protocol Research Type: Cooperative Group
Status: Active - Recruiting
Study Title: E4512 - A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Purpose: This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression.
ClinicalTrials.gov Identifier: NCT02201992
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Alexandra Albertson (802) 656-2178
Information: https://clinicaltrials.gov/ct2/show/NCT02201992?term=4512&rank=1
Institution Number: 15-155
Protocol Research Type: Cooperative Group

 

Last modified January 21 2016 01:54 PM