A Phase II Study of Sotorasib (AMG 510) in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

Date Added
June 2nd, 2021
PRO Number
Pro00110695
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed and previously treated stage IV or recurrent KRAS G12C mutated non-squamous non-small cell lung cancer. The purpose of this study is to see if we lower the chance of the growth or spread of KRASG12C-mutated advanced non-squamous non-small cell lung cancer by using the study drug AMG 510. Participants can expect to be on this study until disease progression, the side effects become too severe, or the participant decides to discontinue the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Date Added
January 19th, 2021
PRO Number
Pro00107224
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with limited-stage small cell lung cancer (LS-SCLC). The investigational drug in this study is atezolizumab. The purpose of this study is to find out if the chance of small cell lung cancer growing or spreading can be lessened by adding an immunotherapy drug (atezolizumab) to the usual treatment regimen. Participants can expect to be on this study for up to one year and followed after study completion for up to 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

Date Added
May 7th, 2020
PRO Number
Pro00099591
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to find out if a targeted immunotherapy treatment will have an effect on specific genes and proteins in tumors. This is a screening study in which a tumor sample will be submitted for testing. Based on results, the participant will be assigned to one of the treatment sub-studies.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

Date Added
September 12th, 2019
PRO Number
Pro00090077
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Resectable Stages II and III Non-small Cell Lung Cancer (NSCLC). The investigational drug in this study is durvalumab. The purpose of this study is to see if durvalumab will work and be safe for the treatment of resectable NSCLC. Participants can expect to be on this study for about 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase lb Study of ASPl948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with a PD-I inhibitor (Nivolumab or Pembrolizumab) in Subjects with Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

This is a research study to find out if the study drug (ASP1948 or ASP1948 plus nivolumab or pembrolizumab) is safe and to determine the safest, most effective dose of the drug. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients. During this study, the study drug will be continuously assessed to determine if it is safe and tolerated by patients taking it. The following adverse events have been reported in more than 10% of patients: fatigue, abdominal pain, decreased appetite, back pain, dyspnea (difficulty breathing), hyponatraemia (low sodium levels), anemia (low red cell count), and constipation. Since these events may occur in patients not taking ASP1948 and since there have been no clinical trials comparing patients taking ASP1948 with those not taking ASP1948, it is difficult to know at this time whether they were caused by ASP1948.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A PHASE 3, OPEN-LABEL, 3-COHORT RANDOMIZED STUDY OF N-803 IN COMBINATION WITH CURRENT STANDARD OF CARE VS STANDARD OF CARE AS FIRST-LINE TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

Date Added
September 25th, 2018
PRO Number
Pro00080330
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with metastatic, non-small cell lung cancer (NSCLC), have not received any prior chemotherapy for metastatic disease, and are eligible to receive pembrolizumab, a FDA approved standard therapy for NSCLC. The investigational drug in this study is N-803. In this research study, participants will be selected by chance to receive either the study drug N-803 n combination with standard of care immunotherapy (Cohort A Experimental) or chemotherapy and immunotherapy (Cohorts B and C Experimental) or you will receive standard of care immunotherapy (Cohort A Control) or chemotherapy and immunotherapy (Cohort B and C Control) alone. The purpose of this research study is to learn more about how safe the study drug is; learn more about the effects of the study treatment on survival; learn how long it will take for the study treatment to show effectiveness and if it does, how long the effectiveness will last. Participants can expect to be in this study for 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma."

Date Added
April 24th, 2018
PRO Number
Pro00076862
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with mesothelioma. This study is to test whether giving one drug, atezolizumab, along with cisplatin and pemetrexed, before surgery and atezolizumab after surgery by vein is safe. Atezolizumab is the experimental cancer drug in this study, which has already been approved for the treatment of patients with bladder cancer and lung cancer. Participants can expect to be in this study for up to a year and followed for side effect for up to three years after study completion.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



-- OR --