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

Lung Non-Small Cell Carcinoma Clinical Trial

Official title: A Phase II Study of Amivantamab in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Status Not yet recruiting

Clinical Trial Summary

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-vmjw works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-vmjw is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-vmjw 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) in participants with MET amplification-positive non-small cell lung cancer (NSCLC) treated with amivantamab (amivantamab-vmjw) within each cohort.

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) within each cohort. II. To evaluate overall survival (OS) within each cohort. III. To evaluate the duration of response among responders within each cohort. IV. To evaluate the frequency and severity of toxicities within each cohort and combined across all study participants.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) prior to treatment on Cycle 1 Day 1, Cycle 3 Day 1, and at first progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA).

II. To establish a tissue/blood repository from participants with refractory non-small cell lung cancer (NSCLC).

OUTLINE:

Patients receive amivantamab intravenously (IV) on days 1 and 2 in week and once a week in weeks 2-4 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computerized tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up for up to 3 years. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Non-Small Cell Carcinoma

• NCT number: NCT06116682
• Study type: Interventional
• Source: SWOG Cancer Research Network
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 16, 2024
• Completion date: May 2029