Trial Title:
Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)
NCT ID:
NCT06385483
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Afatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Afatinib
Description:
Given PO
Arm group label:
Treatment (afatinib)
Other name:
BIBW 2992
Other name:
BIBW-2992
Other name:
BIBW2992
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (afatinib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (afatinib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (afatinib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (afatinib)
Other name:
EC
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (afatinib)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Radionuclide Imaging
Description:
Undergo nuclear study
Arm group label:
Treatment (afatinib)
Other name:
NM
Other name:
Nuclear Medicine
Other name:
nuclear medicine scan
Other name:
radioimaging
Other name:
Radionuclide Scanning
Other name:
Scan
Other name:
Scintigraphy
Summary:
This phase II MATCH treatment trial tests how well afatinib works in treating patients
with cancer that has certain genetic changes. Afatinib is in a class of medications
called kinase inhibitors. It is used in patients whose cancer has a certain mutation
(change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals
cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study
agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of
treatment with targeted study agent in patients with advanced refractory
cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential
predictive biomarkers beyond the genomic alteration by which treatment is assigned or
resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and
imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes
from pre- through post-therapy imaging can predict objective response and progression
free survival and to evaluate the association between pre-treatment radiomic phenotypes
and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive afatinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging
(MRI) during screening and on study, as well as during follow-up as clinically necessary.
Patients also undergo echocardiography (ECHO) or nuclear study throughout the trial as
clinically necessary. Patients undergo biopsies and blood sample collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time
of registration to treatment step (Step 1, 3, 5, 7)
- Patient's tumor must have either of the below, or another aberration, as determined
via the MATCH Master Protocol:
- Activating mutations of EGFR (del 19, L858R) OR
- Any malignancy harboring any of the following mutations: EGFR G719A, G719C,
G719D, G719S EGFR L861Q, EGFR S768I
- Tumors with an exon 20 insertion alone without the above mutations will be
excluded, with the exception of exon 20 insertions approved as inclusion
variants as part of the dynamic actionable mutation of interest (aMOI) process
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
assignment and must have no clinically important abnormalities in rhythm, conduction
or morphology of resting ECG (e.g. complete left bundle branch block, third degree
heart block)
- Patients with known left ventricular dysfunction must have ECHO or a nuclear study
(multigated acquisition scan [MUGA] or first pass) within 4 weeks prior to
registration to treatment and must not have left ventricular ejection fraction
(LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a
site, the LVEF must be > 50% for the patient to be eligible
- NOTE: Pre-treatment LVEF determination in patients without known left
ventricular dysfunction is NOT otherwise required
- Patients must not have known hypersensitivity to afatinib or compounds of similar
chemical or biologic composition
- Patients must have =< grade 1 renal function as defined below:
- Creatinine =< 1.5 x normal institutional limits OR
- Measured creatinine clearance >= 60 mL/min/1.73 m^2 for patients with
creatinine levels above institutional normal or as calculated by the
Cockcroft-Gault equation
- The above renal eligibility criteria should be strictly followed and will
override the MATCH Master Protocol requirements
- Patients must not have had prior treatment with an EGFR tyrosine kinase inhibitor
(TKI) (e.g. afatinib, erlotinib, gefitinib, neratinib, dacomitinib, AZD9291,
cabertinib, CO-1686)
- Patients with non-small cell lung cancer and small cell lung cancer will be excluded
- Patients with a history of interstitial lung disease will be excluded
- Patients with glioblastoma multiforme (GBM) will be excluded
- Patients must have =< grade 1 diarrhea at baseline
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
August 11, 2015
Completion date:
December 6, 2024
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385483
