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

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
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 Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

Date Added
December 5th, 2019
PRO Number
Pro00091168
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 unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (NSCLC). The investigational drug used in this study is durvalumab. This purpose of this study is to see how if durvalumab will work and be safe for the treatment of patients with Stage I/II Non Small Cell Lung Cancer following stereotactic body radiation therapy when compared to placebo. Participants can expect to be in the study for approximately 6 years.

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

QUILT-3.055: A Phase 2b, Multicohort, Open-Label Study of Combination Immunotherapies in Patients who have Previously Received Treatment with PD-1/PD-L1 Immune Checkpoint Inhibitors

Date Added
August 22nd, 2017
PRO Number
Pro00068710
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 an advanced form of cancer and your disease improved or remained unchanged after receiving PD-1/ PD-L1 Checkpoint Inhibitor Therapy. The investigational drug in this study is called ALT-803. Participants will receive the study drug N-803 in combination with an approved PD-1/PD-L1 Checkpoint Inhibitor Therapy (Pembrolizumab, Nivolumab, Atezolizumab, Avelumab or Durvalumab). The purpose of this research study is to test the effectiveness of the study drug, N-803, in combination with Pembrolizumab, Nivolumab, Atezolizumab, Avelumab or Durvalumab) in with advanced forms of cancer that initially had improvement or no change in disease after receiving checkpoint inhibitor therapy and who now have disease worsening. Participation in this study should take approximately 24 months.

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



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