Study on Patritumab Deruxtecan for Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Sponsor: Daiichi Sankyo

Sponsor score: 40

ClinicalTrials ID:NCT04619004

This clinical trial is testing a new treatment, patritumab deruxtecan, for patients with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation and has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of patritumab deruxtecan in shrinking tumors in patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. Participants must have already tried at least one EGFR-targeted therapy and one platinum-based chemotherapy, but their cancer has continued to grow.

Description

In this study, participants will be randomly assigned to one of two groups to receive different doses of the study drug, patritumab deruxtecan. The goal is to determine which dose is more effective and safe for treating advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Cancer must have continued to grow after previous treatments, including osimertinib and at least one platinum-based chemotherapy.
  • Have a specific EGFR mutation (exon 19 deletion or L858R) confirmed by tests.
  • Have at least one tumor that can be measured by scans.
  • Be willing to provide a tumor sample for testing.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.

Exclusion Criteria

  • Have a history of small cell lung cancer or a combination of small cell and non-small cell lung cancer.
  • Have a history of lung diseases like interstitial lung disease or pulmonary fibrosis.
  • Have severe breathing problems due to lung conditions or other illnesses.
  • Be taking high doses of steroids or other immune-suppressing medications.
  • Have cancer that has spread to the brain or spinal cord and is causing symptoms.
  • Have not waited long enough after previous treatments before starting the study.
  • Have previously received certain types of cancer treatments, including HER3 antibodies or topoisomerase I inhibitors.
  • Have unresolved side effects from previous cancer treatments.
  • Have had another active cancer within the past 3 years, except for certain non-threatening cancers.
  • Have uncontrolled heart disease or active infections like hepatitis B, hepatitis C, or HIV.

Locations

FACILITYZIPCITYSTATE
Banner MD Anderson Cancer Center85234GilbertArizona
City of Hope91010DuarteCalifornia
Moores Cancer Center at the UC San Diego Health92093La JollaCalifornia
Pacific Shores Medical Group90813Long BeachCalifornia
USC Norris Comprehensive Cancer Center90033Los AngelesCalifornia
University of California at Irvine92868OrangeCalifornia
Cedars Sinai90048West HollywoodCalifornia
University of Colorado Denver - Anschutz Medical Campus80045AuroraColorado
Florida Cancer Specialists - South33901Fort MyersFlorida
AdventHealth Orlando32804OrlandoFlorida

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