Study on Osimertinib and Abemaciclib for EGFR Mutant Non-Small Cell Lung Cancer After Resistance to Osimertinib

Sponsor: University of California, San Diego

Sponsor score: 40

ClinicalTrials ID:NCT04545710

Provider View

This clinical trial is exploring a new treatment combination of Osimertinib and Abemaciclib for patients with EGFR mutant non-small cell lung cancer (NSCLC) that has become resistant to Osimertinib. The study aims to find out if this combination can help control the cancer.

Patient Parameters

Program Overview

Lung cancer is a leading cause of cancer-related deaths. While treatments for non-small cell lung cancer (NSCLC) with EGFR mutations have improved survival rates, resistance to these treatments can develop. This study is investigating a new approach to overcome resistance by combining Osimertinib with Abemaciclib in patients whose cancer has progressed after Osimertinib treatment.

Description

Lung cancer is a major cause of cancer deaths. Treatments for non-small cell lung cancer (NSCLC) with specific EGFR mutations have improved survival, but resistance to these treatments can occur. Osimertinib is a standard treatment for these mutations, but resistance can develop after about 19 months. This study is testing a new strategy to overcome this resistance by combining Osimertinib with another drug, Abemaciclib, which targets cell cycle genes often altered in lung cancer. The goal is to see if this combination can help patients whose cancer has progressed after Osimertinib.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) with specific EGFR mutations.
  • Cancer must be Stage IV, recurrent, or metastatic and have progressed after Osimertinib treatment.
  • At least one measurable tumor.
  • Age over 18 years.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Recovery from previous chemotherapy or radiotherapy.
  • Adequate organ function based on specific blood tests.
  • Negative pregnancy test for women of childbearing potential.
  • Agree to use contraception during and after the study.
  • Treated and stable brain metastases are allowed.
  • Able to swallow oral medications.

Exclusion Criteria

  • Recent chemotherapy or investigational treatment within three weeks.
  • Recent radiotherapy, except for specific cases.
  • Major surgery within four weeks before starting the study.
  • Allergies to Osimertinib or study drugs.
  • Serious heart conditions or recent heart attack.
  • Not willing to use contraception if of childbearing potential.
  • Pregnant or breastfeeding women.
  • Other active cancers, except certain skin or cervical cancers.
  • Pre-existing lung disease or gastrointestinal disorders affecting drug absorption.
  • Active hepatitis B, C, or HIV infection.
  • Certain heart rhythm abnormalities.
  • Leptomeningeal carcinomatosis.
  • Serious medical conditions that could interfere with the study.
  • Active infections requiring treatment.
  • History of certain heart conditions.
  • Use of medications affecting drug metabolism.
  • Prior treatment with CDK4/6 inhibitors.

Locations

FACILITYZIPCITYSTATE
UCSD Moores Cancer Center92093La JollaCalifornia

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