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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Amivantamab

    Biological/Vaccine

    Given amivantamab-SC

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

88 Participants
are divided into 1 treatment group
Group A: Treatment (amivantamab)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Response rate for amivantamab-subcutaneous

Response rates and associated confidence intervals will be calculated.

Time frame
Up to 3 years

Secondary outcomes

1

Overall survival

Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Time frame
Up to 3 years
2

Progression free survival

Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Time frame
Up to 3 years
3

Duration of response

Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Time frame
Up to 3 years
4

Incidence of adverse events

Toxicity will be evaluated among all participants enrolled on the study (combining the squamous and non-squamous cohorts). With 80 participants, any toxicity can be estimated to within 11% with 95% confidence. Any toxicity with at least 5% prevalence has at least a 98% chance of being observed.

Time frame
Up to 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator