Study on Amivantamab and Lazertinib with Chemotherapy for EGFR-Mutated Advanced Non-Small Cell Lung Cancer After Osimertinib Failure

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT04988295

This clinical trial is testing whether adding the drugs amivantamab and lazertinib to standard chemotherapy can improve treatment outcomes for patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations and has stopped responding to osimertinib.

Patient Parameters

Program Overview

The study aims to find out if combining the drugs amivantamab and lazertinib with chemotherapy drugs carboplatin and pemetrexed is more effective than using just the chemotherapy drugs alone in treating patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. This is for patients whose cancer has progressed after treatment with osimertinib. The study will also look at the safety of these drug combinations and may offer participants the option to continue treatment in an extension phase after the main study is completed.

Eligibility Criteria

Inclusion Criteria

  • Have at least one tumor that can be measured and has not been treated with radiation.
  • Have advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations (Exon 19del or Exon 21 L858R).
  • If there is a history of brain metastases, all brain lesions must have been treated and stable, with no need for further treatment.
  • Have a good overall health status, with an ECOG score of 0 or 1.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to regular pregnancy tests during the study.
  • Must have experienced cancer progression after treatment with osimertinib, which was given as the most recent therapy for advanced disease.
  • Must stop taking osimertinib at least 8 days before starting the study treatment.

Exclusion Criteria

  • Have received radiation therapy for symptom relief less than 14 days before starting the study.
  • Have worsening or symptomatic brain metastases.
  • Have a history of leptomeningeal disease or untreated spinal cord compression.
  • Have a known transformation to small cell lung cancer.
  • Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
  • Have significant heart or blood vessel problems, such as recent blood clots, heart attack, or stroke, and are not on proper blood-thinning medication.

Locations

FACILITYZIPCITYSTATE
Southern Cancer Center, PC36608MobileAlabama
Arizona Oncology Associates85711TucsonArizona
City of Hope91010DuarteCalifornia
Cedars Sinai Medical Center90048Los AngelesCalifornia
University of California Irvine92868OrangeCalifornia
Rocky Mountain Cancer Centers80907Colorado SpringsColorado
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center33308Fort LauderdaleFlorida
University Cancer And Blood Center LLC30607AthensGeorgia
University of Mississippi Medical Center39216JacksonMississippi
Nebraska Cancer Specialists68803Grand IslandNebraska

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