Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the drug is being studied. It also means that the FDA has not
yet approved the drug for your type of cancer or for any use outside of research studies.
It has been found that some people with NSCLC have a change (mutation) in a certain gene
called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC
patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor
therapies, with a high response rate, prolonged progression-free survival and possibly
improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor
an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed
therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially
erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is
ideal for studying other targeted therapeutic strategies that could affect the oncogene
mutation in EGFR via alternative mechanisms.
AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This
drug has been used in other research studies. Information from those other research studies
suggests that AUY922 may be effective in killing cancer cells in patients with exon 20
insertion mutations in EGFR.
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works
for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.
Interested patients will be asked to undergo some screening tests and procedures to confirm
that they are eligible. Many of these tests and procedures are likely to be part of regular
cancer care and may be done even if it turns out that patients do not take part in the
research study. If patients have had some of these tests or procedures recently, they may or
may not have to be repeated. These tests and procedures include: a medical history physical
exam, performance status, assessment of tumor, EKG, electrocardiogram or multigated
acquisition scan, eye exam, blood draw, blood pregnancy test, urine test and collection of a
piece of the stored tumor tissue.
The study treatment is given in 21 day cycles. AUY922 is given by IV (into a vein). This is
called an infusion. Patients will receive an infusion of AUY922 on days 1, 8 and 15 of each
cycle (once per week). The infusion will take about 60 minutes.
A schedule of clinic visits for the study is summarized below.
Cycle 1, Day 1: physical exam, including measurement of vital signs and weight; performance
status; EKG; blood draw; routine urine test Cycle 1, Day 2: EKG Cycle 1, Day 3: EKG Cycle 1,
Day 8: Vital signs, performance status, EKG, questions about side effects and other
medications taken Cycle 1, Day 15: Physical exam, including measurement of vital signs,
performance status; EKG; blood draw; questions about side effects and other medications taken
Note that in Cycle 1 patients will need to stay at (or return to) the clinic for the last EKG
following the Day 1 AUY922 infusion, and come to the clinic on Days 2 and 3 for EKGs.
Cycle 2 and beyond, Day 1: physical exam, including measurement of vital signs and weight;
performance status; EKG; blood draw; questions about side effects and other medications
taken; routine urine test Cycle 2 and beyond, Day 8: Vital signs; performance status; EKG;
questions about side effects and other medications taken Cycle 2 and beyond, Day 15: Physical
exam, including measurement of vital signs; performance status; EKG; blood draw; questions
about side effects and other medications taken.
Additional EKGs may be done at any time if the study doctor thinks it is necessary. A blood
test to measure the amount of cardiac enzymes in the blood may be done whenever abnormal
findings are suspected or seen on the EKG.
Additional tests and procedures:
- CT or MRI scans will be done to measure the disease about every 6 weeks.
- A blood pregnancy test, for women who can become pregnant, will be performed every 6
weeks or at any point in which pregnancy is suspected.
- A standard eye exam will be done on Cycle 3, Day 1. Additional eye exams will be done if
patients experience any eye-related symptoms, such as changes in vision.
Within 1 week after the last dose of the study drug AUY922, patients will be asked to return
to the clinic. At this visit the following will be done: physical examination, performance
status, EKG, ECHO or MUGA scan, blood draw, urine test, eye exam, questions about side
effects and other medications taken. Patients will be asked to return to the clinic a second
time so investigators can follow-up on any ongoing side effects after stopping AUY922.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 |