Study Comparing Patritumab Deruxtecan to Standard Chemotherapy in Advanced EGFR-Mutated Lung Cancer

Sponsor: Daiichi Sankyo

Sponsor score: 40

ClinicalTrials ID:NCT05338970

This clinical trial is testing a new drug, Patritumab Deruxtecan, against standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation and has not responded to previous targeted treatments.

Patient Parameters

Program Overview

This study aims to find out if Patritumab Deruxtecan, a new type of cancer treatment, is more effective than standard chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. The study will compare how long patients live without their cancer getting worse and overall survival between the two treatments.

Description

Patritumab Deruxtecan is a new drug being tested for its ability to treat advanced non-small cell lung cancer (NSCLC) with a specific mutation in the EGFR gene. This drug is designed to target and kill cancer cells more effectively than standard chemotherapy. The main goal of this study is to see if Patritumab Deruxtecan can help patients live longer without their cancer progressing compared to those receiving standard platinum-based chemotherapy. The study will also look at overall survival rates. Participants in this study have advanced NSCLC with an EGFR mutation and have already tried other targeted treatments that did not work.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Have a specific mutation in the EGFR gene (exon 19 deletion or L858R).
  • Previously treated with one or two EGFR-targeted therapies, including a third-generation EGFR TKI.
  • No other prior treatments for advanced NSCLC, such as chemotherapy or immunotherapy.
  • Cancer has progressed while on or after third-generation EGFR TKI treatment.
  • At least one tumor that can be measured by scans.
  • Willing to provide a tumor sample for testing.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood cell counts and organ function based on recent lab tests.

Exclusion Criteria

  • History of small cell lung cancer or squamous NSCLC.
  • History of lung diseases like interstitial lung disease or radiation pneumonitis.
  • Severe breathing problems due to lung conditions.
  • Currently taking high doses of steroids or other immune-suppressing drugs.
  • History of cancer spreading to the brain or spinal cord that is not well controlled.
  • Previous treatment with drugs similar to Patritumab Deruxtecan.
  • History of other cancers within the last 3 years, except for certain skin or cervical cancers.
  • Uncontrolled heart disease.
  • Active hepatitis B or C infection.
  • Uncontrolled HIV infection.
  • Significant eye disease affecting the cornea.

Locations

FACILITYZIPCITYSTATE
Alaska Oncology and Hematology LLC99508AnchorageAlaska
Highlands Oncology72762SpringdaleArkansas
City of Hope91010DuarteCalifornia
Moores Cancer Center at the UC San Diego Health92037La JollaCalifornia
Scripps MD Anderson Cancer Center92037La JollaCalifornia
USC Norris Comprehensive Cancer Center90033Los AngelesCalifornia
Kaiser Permanente - Vallejo Medical Center94589VallejoCalifornia
Innovative Clinical Research Institute90603WhittierCalifornia
Sarah Cannon/Florida Cancer Specialists - FCS South33980Port CharlotteFlorida
Emory University30322AtlantaGeorgia

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