Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.

Eligibility criteria

Qualifiers

Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol

Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay

Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable

Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Amivantamab
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging

Treatment groups

88 Participants
are divided into 1 treatment group

Locations

248
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro72401, Jonesboro United States
University of Arkansas for Medical Sciences72205, Little Rock United States
California
Sutter Auburn Faith Hospital95602, Auburn United States
Alta Bates Summit Medical Center-Herrick Campus94704, Berkeley United States

Sponsors and collaborators

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator