Brief Summary

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

13mo left

Started Apr 2018

Longer than P75 for phase_2

Geographic Reach

1 country

345 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.2 years study duration

Study Progress89%

Apr 2018Jun 2027

First Submitted

Initial submission to the registry

June 16, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed

10 months until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 11, 2026

Status Verified

April 1, 2026

Enrollment Period

9.2 years

First QC Date

June 16, 2017

Last Update Submit

June 10, 2026

Conditions

Advanced Lung Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7 Recurrent Lung Non-Small Cell Carcinoma Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Best objective response
Will be evaluated via Response Evaluation Criteria in Solid Tumors 1.1 criteria. Categorical data, such as response rates (complete response + partial response), will be compared using Fisher's exact tests with a one-sided type I error rate of 10%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. Any continuous outcomes will be analyzed using Wilcoxon rank sum test, and multivariable linear regression models may be used to adjust for multiple associations with outcome. Point estimates of all endpoints will be accompanied by the corresponding two-sided 80% confidence intervals. The method of Atkinson and Brown will be used for the estimation of the confidence interval for response.
Up to 5 years

Secondary Outcomes (3)

Progression-free survival (PFS)
From registration to documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival (OS)
From registration to death from any cause, assessed up to 5 years
Incidence of adverse events
Up to 5 years

Other Outcomes (3)

Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)
Baseline up to 5 years
Biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue
Baseline up to 5 years
Identification of resistance mechanisms to osimertinib through post-progression tumor biopsies and ctDNA
Up to 5 years

Study Arms (1)

Treatment (osimertinib)

EXPERIMENTAL

Patients receive osimertinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA, MRI or CT with contrast, and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Computed Tomography with ContrastProcedure: Echocardiography TestProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanDrug: Osimertinib

Interventions

Echocardiography TestPROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Treatment (osimertinib)

OsimertinibDRUG

Given PO

Also known as: AZD 9291, AZD-9291, AZD9291, Mereletinib

Treatment (osimertinib)

Computed Tomography with ContrastPROCEDURE

Undergo CT with contrast

Also known as: Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast, CT with Contrast

Treatment (osimertinib)

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment (osimertinib)

Multigated Acquisition ScanPROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Treatment (osimertinib)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (osimertinib)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria
An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay
NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
Participants must not have previously received osimertinib
Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
Hemoglobin \>= 9.0 g/L (within 4 weeks before registration)
Leukocytes/white blood cells \>= 3,000/mcL (within 4 weeks before registration)
Absolute neutrophil count \>= 1,500/mcL (within 4 weeks before registration)
Platelets \>= 100,000/mcL (within 4 weeks before registration)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) if no liver metastases or =\< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)
+28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (345)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

ACTIVE NOT RECRUITING

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

ACTIVE NOT RECRUITING

Alaska Breast Care and Surgery LLC