A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Date Added
July 1st, 2022
PRO Number
Pro00120871
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with Stage IV or Recurrent Non-small cell lung cancer previously treated with Anti-PD-1 or Anti-PD-L1 therapy. The purpose of this study is to compare the usual treatments to using N-803 (ALT-803) plus pembrolizumab. N-803 (ALT-803) is an experimental drug that may activate someone's natural killer cells so that they can stimulate an immune response to help fight cancer. Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. This immunotherapy drug combination, N-803 (ALT-803) plus pembrolizumab, is not approved by the FDA for use in advanced lung cancer. 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

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


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

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

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

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 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



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