Study on Necitumumab and Trastuzumab Combined with Osimertinib for Treating Advanced EGFR-Mutated Lung Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT04285671

Provider View

This clinical trial is testing a combination of drugs, including necitumumab, trastuzumab, and osimertinib, to see if they can effectively treat stage IV non-small cell lung cancer that has a specific EGFR mutation and has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining the drugs necitumumab and trastuzumab with osimertinib can help treat stage IV non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene and has become resistant to osimertinib alone. These drugs may help the immune system attack cancer cells and stop them from growing and spreading. The study will look at the best dose of these drugs and how well they work together compared to osimertinib alone.

Description

This study is divided into two phases: Phase Ib and Phase II.

In Phase Ib, researchers will determine the best dose of the drug combination for future studies. In Phase II, they will evaluate how effective the combination is in shrinking tumors and improving patient outcomes.

The study will also assess the safety of the treatment by monitoring any side effects experienced by participants. Additionally, researchers will explore how the treatment affects patients' quality of life and look for biological markers that might predict how well patients respond to the treatment.

Participants will receive necitumumab and trastuzumab through an IV on specific days, and take osimertinib orally every day. The treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable. After completing the treatment, participants will have follow-up visits to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to provide informed consent.
  • Have stage IV non-small cell lung cancer with a specific EGFR mutation.
  • Cancer must have progressed after treatment with osimertinib.
  • Must have measurable disease according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Must be able to swallow pills and have no known allergies to the study drugs.
  • Must meet specific blood count and organ function requirements.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after.
  • Male participants must agree to use condoms during the study and for 180 days after.
  • Must agree not to donate blood, sperm, or eggs during the study and for a specified period after.

Exclusion Criteria

  • Currently enrolled in another clinical study, unless only in follow-up.
  • Have received other cancer treatments recently, except for osimertinib.
  • Have had prior treatment with certain combinations of EGFR/HER-targeting therapies.
  • Have not recovered from side effects of previous treatments, except for certain conditions.
  • Have small cell lung cancer or a history of certain heart conditions.
  • Have ongoing infections or other serious medical conditions.
  • Are pregnant or breastfeeding, or planning to conceive during the study.
  • Have untreated or symptomatic brain metastases.
  • Have had recent major surgery or other cancers within the past two years.
  • Have gastrointestinal disorders affecting drug absorption.
  • Have a history of blood clots within three months prior to the study.
  • Have received a yellow fever vaccine recently.

Locations

FACILITYZIPCITYSTATE
UCLA / Jonsson Comprehensive Cancer Center90095Los AngelesCalifornia

Get This Program In Your Inbox

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