Study on the Effectiveness and Safety of Dato-DXd With or Without Osimertinib Compared to Standard Chemotherapy in Patients with EGFR-Mutated Advanced Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06417814

Provider View

This clinical trial is testing a new treatment, Dato-DXd, alone or with osimertinib, against standard chemotherapy to see which is more effective in slowing down the progression of advanced lung cancer with specific genetic mutations.

Patient Parameters

Program Overview

The study aims to find out if Dato-DXd, either by itself or combined with osimertinib, is better at controlling advanced non-small cell lung cancer (NSCLC) with EGFR mutations compared to the usual platinum-based chemotherapy. Researchers will measure how long patients live without their cancer getting worse.

Description

This Phase III study involves three groups of patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes (EGFR mutations) and has worsened after previous treatment with osimertinib. Participants will be randomly assigned to one of three treatment groups: 1) Dato-DXd with osimertinib, 2) Dato-DXd alone, or 3) standard platinum-based chemotherapy. Patients will continue their assigned treatment until their cancer progresses, they experience unacceptable side effects, or meet other criteria for stopping treatment. After stopping treatment, participants will have a follow-up visit within 35 days and a safety check about a month after their last dose.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
  • Must have specific EGFR mutations that respond to certain treatments.
  • Cancer must have worsened after treatment with osimertinib.
  • No more than two previous treatments with EGFR-targeting drugs.
  • At least one measurable tumor that has not been treated with radiation.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood cell counts and organ function before starting the study.

Exclusion Criteria

  • Previous use of chemotherapy or other cancer treatments in the metastatic setting.
  • History of another cancer unless treated and inactive for at least two years.
  • Severe or uncontrolled health conditions, such as active infections or heart disease.
  • Significant fluid buildup in the body that cannot be managed.
  • History of lung inflammation or current lung issues that cannot be ruled out.
  • Severe lung function problems due to other illnesses.
  • Unstable spinal cord or brain issues.
  • Active brain metastases causing symptoms.
  • Serious eye conditions affecting the cornea.
  • Uncontrolled infections requiring strong medications.
  • Uncontrolled HIV infection.

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