Expanded Access to Mobocertinib for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon20 Insertion Mutations

Sponsor: Millennium Pharmaceuticals, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04535557

Provider View

This program offers access to the drug mobocertinib for patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic mutation and have already tried other treatments.

Patient Parameters

Program Overview

The aim of this program is to provide access to mobocertinib for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. This is for patients who have already tried at least one other treatment for their cancer.

Description

Mobocertinib is a medication being offered to patients with non-small cell lung cancer (NSCLC) that has a specific mutation known as EGFR exon-20 insertion. This program is for patients whose cancer has not responded to standard treatments and who have no other approved treatment options. Patients will continue taking mobocertinib until their cancer progresses and requires a different treatment, they experience side effects that cannot be tolerated, or another reason for stopping arises. If the doctor believes the patient is still benefiting, treatment may continue even if the cancer progresses.

The program plans to include about 100 patients, based on requests from patients. All participants will receive a dose of 160 mg of mobocertinib. If side effects occur, the dose may be reduced to 120 mg or 80 mg, depending on the doctor's judgment.

This program will take place at multiple centers in the United States. Participation in this expanded access program lasts about 4 months, with follow-up for survival continuing for up to 30 days after the last dose and until the patient stops participating.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery.
  • Have a specific genetic mutation called EGFR exon 20 insertion.
  • Have tried at least one previous treatment for advanced or metastatic cancer.
  • Be in relatively good health, with a performance status score between 0 and 2.
  • Have a normal heart rhythm as shown by an ECG test, with specific QT interval limits for men and women.

Exclusion Criteria

  • Have received other cancer treatments within 14 days before starting mobocertinib, except for certain EGFR inhibitors which are allowed up to 7 days before.
  • Have had radiation therapy within 14 days before starting mobocertinib, unless it was palliative radiation outside the chest and brain, which is allowed up to 7 days before.
  • Have active brain metastases unless treated with surgery or radiation.
  • Have current spinal cord compression or cancer spread to the brain's lining.
  • Have significant heart problems, such as recent heart attack, unstable chest pain, heart failure, or abnormal heart rhythms.
  • Have a prolonged QT interval or are taking medications that can cause heart rhythm problems.
  • Have diarrhea related to previous cancer treatments.

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