Trial Title:
Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)
NCT ID:
NCT06303167
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Osimertinib
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:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (osimertinib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (osimertinib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (osimertinib)
Other name:
EC
Intervention type:
Procedure
Intervention name:
Multigated Acquisition Scan
Description:
Undergo MUGA
Arm group label:
Treatment (osimertinib)
Other name:
Blood Pool Scan
Other name:
Equilibrium Radionuclide Angiography
Other name:
Gated Blood Pool Imaging
Other name:
Gated Heart Pool Scan
Other name:
MUGA
Other name:
MUGA Scan
Other name:
Multi-Gated Acquisition Scan
Other name:
Radionuclide Ventriculogram Scan
Other name:
Radionuclide Ventriculography
Other name:
RNV Scan
Other name:
RNVG
Other name:
SYMA Scanning
Other name:
Synchronized Multigated Acquisition Scanning
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Given PO
Arm group label:
Treatment (osimertinib)
Other name:
AZD 9291
Other name:
AZD-9291
Other name:
AZD9291
Other name:
Mereletinib
Intervention type:
Procedure
Intervention name:
Radiologic Examination
Description:
Undergo radiologic evaluation
Arm group label:
Treatment (osimertinib)
Other name:
Radiologic Evaluation
Other name:
Radiologic Exam
Summary:
This phase II MATCH treatment trial evaluates the effectiveness of osimertinib (AZD9291)
in treating patients with cancer that has certain genetic changes called EGFR mutations.
Osimertinib is in a class of medications called kinase inhibitors. It works by blocking
the action of mutant forms of the EGFR protein, which play a key role in tumor cell
growth. Osimertinib may cause tumor cell death and inhibit tumor growth in
EGFR-overexpressing tumor cells, thereby stopping or slowing the spread of tumor 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 osimertinib (AZD9291) 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. Patients also undergo radiologic evaluation throughout the trial,
echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening, and
biopsy and collection of blood samples on trial and at end of treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years
and then every 6 months for 1 year.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable
documents.
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
- Patient must fulfill all eligibility criteria outlined in MATCH Master Protocol at
the time of registration to treatment step (step 1, 3, 5, 7)
- Patients must have either of the below, or another aberration, as determined via the
MATCH Master Protocol:
- Any malignancy except non-small cell lung cancer (NSCLC) with EGFR T790M
identified in their tumor, with or without an activating mutation OR
- Any malignancy harboring any of the following mutations: EGFR G719A, G719C,
G719D, G719S EGFR L861Q, S786I or an EGFR exon 19 in frame insertion mutation
- 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, and second-degree heart block
- Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks
prior to registration and must not have a 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
- Patients must not have known hypersensitivity to osimertinib (AZD9291) or compounds
of similar chemical or biologic composition or any of the inactive excipients of the
tablets
- Patient must not have received osimertinib (AZD9291), WZ4002, CO-1686, HM61713,
EGF816 or ASP8273 previously
- Patients known to harbor germline EGFR T790M mutations are excluded from the study.
Prospective testing for germline mutations is not required
- Patients must not have a history of interstitial lung disease, idiopathic pulmonary
fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced
pneumonitis, idiopathic pneumonitis, radiation pneumonitis requiring steroids, or
evidence of active pneumonitis on screening chest computerized tomography (CT) scan.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Patients must not currently be receiving treatment with potent CYP3A4 inducters or
medications "known to prolong" the QT interval. Drugs that "may possibly prolong"
the QT interval, are permitted if the patient has been stable on therapy for the
period indicated for the specific medication
- Patients must agree to not donate sperm from the start of protocol treatment until
at least 4 months after the last dose of protocol treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 8, 2016
Completion date:
December 31, 2025
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/NCT06303167