Study Comparing Amivantamab with Chemotherapy to Chemotherapy Alone in Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT04538664

This clinical trial is evaluating whether adding the drug amivantamab to standard chemotherapy can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation known as EGFR Exon 20 insertions.

Patient Parameters

Program Overview

The aim of this study is to determine if combining the drug amivantamab with chemotherapy is more effective in extending the time patients live without their cancer worsening, compared to chemotherapy alone. This study focuses on patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR Exon 20 insertions.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation known as EGFR Exon 20 insertions.
  • Have measurable cancer according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to have genetic testing of the tumor through a biopsy before starting treatment, and provide blood samples during the study to monitor tumor mutations.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to regular pregnancy tests during the study.

Exclusion Criteria

  • Have another type of non-small cell lung cancer (NSCLC) at the same time.
  • Have untreated brain metastases, unless they have been treated and are stable without symptoms or steroid use for at least two weeks.
  • Have a history of spinal cord compression that has not been treated with surgery or radiation.
  • Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
  • Cannot take carboplatin or pemetrexed due to medical reasons or allergies, or have allergies to vitamin B12 or folic acid.

Locations

FACILITYZIPCITYSTATE
City of Hope 291010DuarteCalifornia
University of California Irvine92868OrangeCalifornia
UCLA90404Santa MonicaCalifornia
Georgetown University Hospital20007Washington D.C.District of Columbia
H. Lee Moffitt Cancer & Research Institute33612TampaFlorida
University Cancer And Blood Center LLC30607AthensGeorgia
Henry Ford Hospital48202DetroitMichigan
Washington University Medical Center63110St LouisMissouri
Regional Cancer Care Associates LLC08816East BrunswickNew Jersey
Langone Health at NYC University, NYU School of Medicine10016New YorkNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.