Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Lung


Title: SWOG S0819: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/BevacizumabWith or Without Concurrent Cetuximab In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC).

Description: The purpose of this study is to compare the effects, good and/or bad, of cetuximab on lung cancer.


Contact: Sylvia Alarcon
Email: sva24@georgetown.edu
Phone: 202-687-7606


Title: A Pilot Prospective Study Correlating CYP19A1 Polymorphisms with Estrogen Alpha/Beta Receptor Expression and Hormonal Levels in Postmenopausal African American Females Compare to White Females with Newly Diagnosed Non-Small Cell Lung Cancer (NSCLC) Tumors.

Description: Recent research shows that many lung cancers are influenced by hormones. Targeting hormonal receptors has revolutionized the way that certain cancers are treated. Research is currently underway to determine whether lung cancer can also be controlled implementing hormonal methods.

Currently there is no conclusive evidence if having higher estrogen or other hormonal levels in the blood predispose y to hormonal sensitive lung cancers. This study will attempt to see whether lung cancer is hormonally sensitive.

Also, there has been recent research showing that genetic variations in Japanese females, may predispose them towards certain types of lung cancer. Currently it is not known whether African American or Caucasian females are similarly predisposed to lung cancer because of these genetic variation called single nucleotide polymorphisms (SNPs). This study will attempt to clarify whether this is the case.



Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer

Description: This is a randomized phase II/III study to test the safety and tolerability of the research study drug, MK-3475 compared to the standard of care, docetaxel for squamous non-small cell lung cancer, measured by the rates of response to treatment and survival. Both Mk-3475 and docetaxel will be given intravenously (through a needle in a vein) once every three weeks. Treatment will be assigned by chance (randomized) to one of the following groups: MK-3475 at a dose of 2mg/kg or 10mg/kg OR Docetaxel at a dose of 75 mg per area of your body according to a specific formula. Patients will be seen in clinic for treatments, routine care, and safety evaluations. Patients will also be seen for a 30 day follow up after their last dose of medication.


Contact: Erica Sondergaard
Email: els71@georgetown.edu
Phone: 202-687-1116


Title: CO-1686-008 - A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Description: The drug being investigated in this study is called CO-1686. CO-1686 is not approved by the US Food and Drug Administration (FDA) and is being studied in people with lung cancer to find out if it is safe, and if it helps stop tumors from growing.

This study has two parts. The first part of the study was open to people whose lung cancer had mutations, and whose cancer came back after treatment with other cancer drugs . The main goal of Part 1 of the study was to help decide the best dose level of CO-1686 to begin the actual testing in Part 2.

Part 2 of the study is only open to people with lung cancer who have a mutation called T790M and whose cancer came back after treatment with other cancer drugs.



Title: A7471047: Phase 2 Open-Label Trial of Oral Intermittent Dacomitinib in Patients with Advanced NSCLC.

Description: The purpose of this study is to evaluate the safety and efficacy of an intermittent regimen of dacomitinib in subjects with non-small cell lung cancer.


Contact: Sylvia Alarcon
Email: sva24@georgetown.edu
Phone: 202-687-7606


Title: A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients with Acquired Resistance to Erlotinib.

Description: Subjects with non-small cell lung cancer (NSCLC) that has been already started to spread to other places in the body (metastatic) and have already received treatment with a drug called erlotinib will participate in this study.

In order to participate in this study, a piece of a sample taken from their tumor will be tested for a protein called “MET”. Only patients with a “MET” positive test result can participate in this study. This test is not approved by regulatory authorities other than for use in clinical studies.

This study is being done to see how safe an investigational drug, LY2875358, is and how well it will work to help people with non-small cell lung cancer (NSCLC) that has already started to spread to other places in the body (metastatic). “Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). However the FDA has allowed the use of this drug for research.

The primary purpose of subjects' participation in this study is to help answer the following research question, and not to provide treatment for the subjects condition.



Title: A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged advanced nonsmall cell lung cancer who have been treated previously with chemotherapy and crizotinib.

Description: This study is for patients with ‘anaplastic lymphoma kinase (ALK) positive’ advanced Non-Small Cell Lung Cancer (NSCLC). This means that a particular protein is fused to the ALK gene, this gene fusion promotes and maintains the behavior of cancer cells in the body and causes lung cancer to get worse.

The purpose of this study is to compare the benefit and safety profile of LDK378 against a standard chemotherapy medicine. Subjects may get either LDK378 or one of two standard chemotherapy medicines based on the Study Doctor’s choice. This standard chemotherapy medicine may either be pemetrexed or docetaxel.

LDK 378 is called a ‘targeted’ medicine. This means it targets particular processes which are not working properly in cancer cells in the body, which we think causes disease. There is evidence that the medicine will help to keep disease under control. It is a medicine which has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with this specific type of disease. The medicine being tested in this study is currently not available to buy in any country.

Pemetrexed and docetaxel are standard chemotherapy medicines commonly used to treat this type of cancer. They have been approved by the FDA for the treatment of people with this medical condition. Neither one of these medicines are made by Novartis, the Sponsor of this clinical research study.




Description: The purpose of this study is to test the safety and effects of an experimental drug called MPDL3280A in subjects with PD-L1-positive lung cancer. The use of MPDL3280A in this research study is experimental, which means that it is not yet approved by the U.S. Food and Drug Administration (FDA) for cancer treatment or any other disease.



Title: 59R5-003: A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Cisplatin in Subjects with Untreated Extensive Stage Small Cell Lung Cancer

Description: Many current cancer therapies often produce an initial reduction in tumor size but may not have long-term benefits. One possible explanation for this is the presence of a specific type of cancer cell known as a cancer stem cell. Cancer stem cells make up a small part of the tumor but are believed to be responsible for much of the growth and spread of the cancer. Cancer stem cells may also be more resistant to traditional types of therapy, such as chemotherapy and radiation therapy.

The study drug, OMP-59R5, used in this study is experimental. This means that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. OMP-59R5 is a humanized monoclonal antibody and was developed to target cancer stem cells. OMP-59R5 may block the growth of cancer stem cells, and/or the remaining tumor cells.

This study consists of two parts and you will participate in one of the two parts. The purpose of the first part is to test the safety and to determine the highest tolerable dose of OMP-59R5, when given in combination with etoposide and cisplatin. Etoposide and cisplatin are drugs that are a standard treatment for extensive small cell lung cancer. The purpose of the second part is to test if OMP-59R5, when given in combination with etoposide and cisplatin, is able to shrink or slow tumor growth or increase how long subjects with extensive small cell lung cancer live.

Although OMP-59R5 has been given to cancer patients, it has not been given in combination with etoposide and cisplatin. It is not known if it will provide any benefit to you and may cause harmful side effects.



Title: A Phase II, Multicenter, Single-Arm Study Of MPDL3280A In Patients With Pd-L1−Positive Locally Advanced Or Metastatic Non−Small Cell Lung Cancer.

Description: The purpose of this study is to look at the effects, good or bad, of MPDL3280A on non-small cell lung cancer (NSCLC). MPDL3280A is an experimental drug, which means that health authorities like the U.S. Food and Drug Administration (FDA) have not approved MPDL3280A for the treatment of NSCLC or any other disease.

MPDL328880A is an antibody (a protein produced by the body's immune system) that affects the immune system by blocking the programmed cell death-1 ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body's natural immune responses, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD-L1 pathway, MPDL3280A may help the immune system stop or reverse the growth of tumors.

Blood, tissue samples and related medical information collected during this study will be used by Sponsor researchers and other researchers partnering with the Sponsor for research related to NSCLC or how MPDL3280A works.



Title: CDKO-125a-007: Phase II study of oral PHA-848125AC in patients with malignant thymoma previously treated with multiple lines of chemotherapy.

Description: You are being asked to participate in this study because you have thymus cancer that has previously been treated with chemotherapy. 

You are being asked if you want to take part in a research study using an experimental drug called PHA-848125AC. This means that PHA-848125AC has not been approved by the U.S. Food and Drug Administration (FDA). PHA-848125AC is a new drug that is being studies in humans because of its antitumor activity in research studies done in the laboratory. This drug acts by blocking specific proteins (called cyclin-dependent kinases) involved in how cells divide. In the case of tumor cells the normal control of how cells divide is altered and leads to abnormal cell growth. Experiments have shown that PHA-848125AC may block this uncontrolled cell growth. Treatment with PHA-848125AC may help stop your tumor from growing. All subjects will be all treated at the same dose of PHA-848125AC; this dose has been selected based on results of the first clinical study in solid tumors patients where patients treated at this dose had mild/moderate reversible adverse events, mainly nausea, vomiting, diarrhea and tremors. The dose of PHA-848125AC will never be increased and could be reduced based on the side effects you experience.