IRB #

STUDY00022772

Title

[NCI CIRB] S1900E - A Phase II Study of 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)

Principal Investigator

Jeremy Cetnar

Study Purpose

The purpose of this study is to determine if we can lower the chance of the growth or spread of KRAS-mutated advanced non-squamous non-small cell lung cancer by using the study drug of AMG 510. We also want to find out if this approach is better or worse than the usual approach for lung cancer.

Medical Condition(s)

Non-squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Participants must be assigned to S1900E. Assignment to S1900E is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900E is based on the identification of a KRASG12C mutation.

Participants must have confirmed Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). Mixed histology NSCLC with less than 50% squamous component is allowed.

Participants must have measurable disease documented by CT or MRI within 28 days prior to study registration.

Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC.

Participants must have progressed (in the opinion of the treating physician) following the most recent line of systemic therapy for NSCLC.

Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to substudy registration.

Participants must not have received prior AMG 510 or other KRASG12C specific inhibitor.


Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

3 years from registration

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

SWOG

Recruitment End

02/08/2024

Compensation Provided

No


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