Access to Capmatinib for Treating MET Exon 14 Skipping Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04741789

Provider View

This program provides access to the drug Capmatinib for patients with a specific type of lung cancer known as MET exon 14 skipping NSCLC. It outlines the treatment plan and monitoring guidelines for doctors.

Patient Parameters

Program Overview

This program is designed to help doctors treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called MET exon 14 skipping. Doctors must follow the treatment guidelines and comply with local laws and regulations. The program ensures that patients receive Capmatinib, a medication that targets this specific type of lung cancer.

Description

Before a patient can join this program, their doctor must submit a request through the Novartis system, explaining why the patient needs Capmatinib and providing their medical history. The request is reviewed to ensure the patient meets the program's criteria. Once approved, the patient can start receiving the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic change called MET exon 14 skipping.
  • In the European Union, patients must have received a prior treatment.
  • Must have good organ function, as shown by specific blood test results:
    • Kidney function (creatinine clearance) of at least 45 mL/min.
    • Total bilirubin level no more than 1.5 times the normal limit.
    • Liver enzymes (AST and ALT) within specific limits, with higher allowances for those with liver metastasis.
    • Alkaline phosphatase level no more than 5 times the normal limit.
    • Serum amylase and lipase levels within specific limits.
  • Must provide written informed consent before starting treatment.

Exclusion Criteria

  • Allergic to any ingredients in Capmatinib.
  • Have or had lung diseases like interstitial lung disease or pneumonitis.
  • Recently had radiation therapy to the lungs or other areas and have not recovered from side effects.
  • Had major surgery recently and have not recovered.
  • Taking certain medications that affect how Capmatinib is absorbed or processed by the body.
  • Unable to swallow tablets.
  • Have other severe medical or psychiatric conditions that could increase treatment risks.
  • Recently received live vaccines.
  • Pregnant or breastfeeding women.
  • Women who can become pregnant must use effective birth control during treatment and for 7 days after.
  • Men must use condoms during treatment and for 7 days after to prevent passing the drug to partners or fathering a child.

Get This Program In Your Inbox

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