Clinical Trials for Lung

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Alliance A081801

A081801 Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO

Patients are being asked to take part in this research study because they had non-small cell lung cancer removed, and the cancer has a change in the gene called the PD-L1 gene.

The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The addition of pembrolizumab to the usual treatment could prevent it from returning, however it could also cause side effects.

This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the pembrolizumab increases the life of patients by 1.5 years or more compared to the usual approach.

This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer.

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Principle Investigator: James Lee, M.D.

CTSU A151216

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This trial is trying to see if tumor genetic testing would be helpful at guiding treatment. The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. A genetic test will be done to learn if the tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is the unique genetic material that carries the instructions for your body's development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.
We are interested to see if the tumor tissue might have one of the following two genetic changes:
• Genetic changes in ALK (this will be referred to as ALK )
• Genetic changes in EGFR (this will be referred to as EGFR)
ALK and EGFR are both proteins found on the surface of cells. If the tumor is found to have one of these genetic changes the patient may be invited to participate on a trial that will look at drugs which may target tumors that have these specific genetic changes.
If the tumor is not found to have the genetic changes in ALK or EGFR, the doctor will provide other options for care and the patient will be followed for 5 years. A doctor or research staff will contact the patient every 6 months for 5 years to determine the status of their cancer and overall health. This will help doctors better understand what happens to patients receiving the standard treatment for the disease.

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Principle Investigator: James Lee, M.D.

ECOG 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

Patients are being asked to take part in this research study because they have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. In ALK-positive non-small cell lung cancer, molecular changes make the ALK molecule very active and important for cancer growth and progression. Thus, these cancers may respond to treatment with ALK inhibitors. People who are not in a research study are usually monitored after their initial treatment (which may also include chemotherapy and/or radiation therapy) in case their cancer returns. The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent the cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long patients are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach. The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib (or placebo) will be prescribed for earlier stage disease after the cancer has been surgically removed. A placebo is a capsule that looks like the study drug but contains no medication.
Patients taking low dose Methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study.

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Principle Investigator: James Lee, M.D.

ECOG EA5191

A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Patients are being asked to take part in this research study because they have advanced non-squamous non-small cell lung cancer which has either grown or has recurred.
This study is being done to answer the following question:
Can we lower the chance of lung cancer from growing or spreading with an oral drug called cabozantinib? In this study, we are testing cabozantinib by itself and also with the immune drug, nivolumab.
We are doing this study because we want to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as care most people get for lung cancer, and for this study is chemotherapy given intravenously (IV).
The purpose of this study is to compare the two investigational treatments (cabozantinib alone to using cabozantinib plus the usual treatment nivolumab) to the current standard of care second line therapy. . We know from prior studies that the pill therapy cabozantinib can control the growth of NSCLC by itself, but it is possible that it will work better by adding immunotherapy with nivolumab. The FDA approved treatment options for NSCLC after prior chemotherapy and immunotherapy includes chemotherapy with docetaxel, with or without ramucirumab. Other standard of care chemotherapies include gemcitabine, paclitaxel, and nab-paclitaxel. The addition of cabozantinib to the usual treatment (nivolumab) could shrink the cancer and/or prevent it from growing for a period of time. But, it could also cause side effects.
This study will help the study doctors find out if either treatment with cabozantinib, or treatment with cabozantinib plus nivolumab, is better, or the same as, the standard chemotherapy approach. To decide if it is better, the study doctors will be looking to see if either of these study treatments control cancer growth in patients for a longer time than the standard chemotherapy.

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Principle Investigator: James Lee, M.D.

IRB-200467

The COVID-19 and Cancer Consortium (CCC19) Registry

Cancer patients have an almost unique risk profile in this pandemic. Many patients, especially those actively on treatment, have high levels of contact with the healthcare system. This can include doctor’s visits, phlebotomy, imaging, social work and financial consultations, and infusion room visits for anti-cancer drugs and supportive care such as blood transfusions. Most of these locations are shared spaces by necessity, putting patients at an increased risk for COVID-19 exposure. Additionally, many if not all cancer patients are immunocompromised, through the immunosuppressive effects of anti-cancer drugs, supportive medications such as steroids, and the cancer itself.

Early reports on the prognosis for cancer patients are conflicting and for the most part non-peer-reviewed. To our knowledge the largest study published to date includes 18 patients with cancer, who were shown to have increased risk for severe events in multivariate analysis. Lung cancer was the most common malignancy, comprising 5/18 (28%) of the cohort. Importantly, only five of the 18 patients were known to be on active systemic anti-cancer therapy. These numbers are too small to understand the true impact of COVID-19 on cancer patients, particularly those on active treatment.

Given this acute lack of knowledge and concern for extreme vulnerability, we formed a new consortium, the COVID-19 and Cancer Consortium (CCC19). The driving goal of the consortium is to collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals. No protected health information (PHI), as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), will be collected by this centralized registry.

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Principle Investigator: Matthew Puc, M.D.

SWOG LUNGMAP

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)” (NCT 03851445)

Patients are being asked to take part in this research study because they have non-small cell lung cancer. They are asked to submit a tumor sample to test for specific genes and proteins. Based on the test results, they will be assigned to one of the treatment sub-studies.
The study is being done to find out if a targeted or immunotherapy treatment will have an effect on specific genes and proteins in the tumor.
The purpose of this study screening step is to test specific genes and proteins in the tumor sample.
Pre-Screening: Patients are considered in pre-screening if they are currently receiving cancer treatment. They will continue with the current treatment as long as it is continuing to help them. However, if the tumor begins to grow, pre-screening will make it easier for them to take part in one of the treatment studies matching the tumor to an appropriate study drug.
Screening: Patients are considered in screening if they have experienced tumor growth.
Based on the test results, they will be assigned to one of the treatment studies. We do not know how accurate this screening will be in matching the tumor type to a drug to treat the tumor.
We expect that between 750 and 1250 patients will be screened for this study each year. We also expect that about 400 to 500 patients per year will go on to receive treatment on one of the assigned treatment studies.

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Principle Investigator: James Lee, M.D.

SWOG S1900B

A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Patients are being asked to take part in this research study because they have non-small cell lung cancer that has spread outside the lungs. The tumor sample has a biological marker, which is positive for a RET gene fusion. If a gene change (mutation) affects one or more proteins in a pathway, the proteins may not be able to be turned on or off as expected. This can cause cells to grow out of control and lead to cancer.
The purpose of this study is to test the good and bad effects of the drug called LOXO-292. LOXO-292 could shrink the cancer, but it could also cause side effects. Another purpose of this study is for the study doctors to learn if a biomarker test for RET fusions is helpful in assigning treatment.

LOXO-292 is not approved by the FDA for use in advanced non-small cell lung cancer.

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Principle Investigator: James Lee, M.D.

 

Contacts for Participation in Clinical Trials:

Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
(856) 206-4721
tcarducc@virtua.org

Voorhees
Karen Goldsmith, BSN, RN
Protocol Coordinator
(856) 247-7395
kgoldsmith@virtua.org

Maria Jenkins, CCRP
Clinical Research Coordinator
(856) 247-7396
mdjenkins@virtua.org