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Lung Cancer Research

Study Title:  International Early Lung Cancer Action Program (I-ELCAP)

Study Purpose: Determine the efficacy of low dose helical chest CT scan screening in reducing mortality of lung cancer.

Participants: Age 55-75 with a minimum 20 pack year smoking history (the equivalent of 1 pack/day for 20 years), without manifestations of lung cancer.

Principal Investigator: James C. Willey, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  A151216:  Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).  (NCT02194738)

Study Purpose: This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


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).  (NCT02193282)

Study 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.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  E4512:  A Phase 3 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.  (NCT02201992)

Study 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 anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) - A Randomized Phase 3 Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers.  (NCT02595944)

Study Purpose:   This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  S1400:  A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung MAP Study) (NCT02154490)

Study Purpose:  This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval. 

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  S1400B:  A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study) (NCT02785913)

Study Purpose:  This phase II trial studies how well taselisib (GDC-0032) works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the phosphoinositide 3-kinase (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease the activity of PI3K and may be able to shrink tumors.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794 


Study Title:  S1400D:   A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study) (NCT02154490)

Study Purpose:  This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794


Study Title:  S1400I:   A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP Sub-Study) (NCT02785952)

Study Purpose:  This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Principal Investigator: Roland Skeel, MD

Study Coordinator: Stephanie Smiddy, RN. For more information please contact 419-383-6794

 

 

Last Updated: 9/20/16