Access to Amivantamab for Patients with Advanced Non-Small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04599712

Provider View

This program provides access to the drug amivantamab for patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic mutation and whose cancer has worsened after standard chemotherapy.

Patient Parameters

Program Overview

The goal of this program is to offer the drug amivantamab to patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation known as EGFR exon 20 insertion. This is for patients whose cancer has spread and has not improved with standard platinum-based chemotherapy. The program is intended for those with serious conditions where no other treatments are available or effective.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) with a specific genetic mutation called EGFR exon 20 insertion.
  • Have already received treatment with platinum-based chemotherapy. If unable to receive platinum, may qualify if treated with other approved or investigational treatments targeting the mutation.
  • Have a life expectancy of at least 3 months and good liver, kidney, lung, and heart function as assessed by a doctor.

Exclusion Criteria

  • Have a history of lung diseases like interstitial lung disease (ILD) or lung inflammation from drugs or radiation that needed treatment with steroids or other immune-suppressing drugs in the last 3 months.
  • Have active or symptomatic cancer spread to the brain or spinal fluid.
  • Have unresolved or untreated brain tumors.
  • Have known allergies or reactions to amivantamab or similar drugs.
  • Are pregnant or breastfeeding.

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