Phase III Study Comparing Datopotamab Deruxtecan and Docetaxel for Advanced TROP2-positive Non-squamous Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07291037

This clinical trial is testing the effectiveness and safety of a new drug, datopotamab deruxtecan, compared to the standard treatment, docetaxel, for patients with advanced lung cancer that is TROP2-positive and does not have certain genetic changes.

Patient Parameters

Program Overview

The TROPION-Lung17 study aims to find out if the new drug datopotamab deruxtecan (Dato-DXd) is more effective and safer than the standard drug docetaxel for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is TROP2-positive and lacks specific genetic changes that can be targeted by other treatments.

Description

This study is a Phase III trial, meaning it is in the later stages of testing. It involves two groups of participants: one group will receive the new drug datopotamab deruxtecan (Dato-DXd), and the other will receive the standard treatment, docetaxel. The study is open-label, so both the participants and the researchers know which treatment is being given. The trial is being conducted at multiple centers and focuses on patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is TROP2-positive and does not have certain genetic changes that can be treated with other drugs. The study will also evaluate a diagnostic test used to identify TROP2-positive patients.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without specific genetic changes that can be treated with targeted therapies.
  • Must test negative for certain genetic changes, including EGFR, ALK, and ROS1.
  • Cancer must be TROP2-positive.
  • Disease must have worsened after previous treatment.
  • Must have received platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 treatment.
  • Provide a tumor sample for TROP2 testing.
  • Have at least one measurable tumor that has not been treated with radiation.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate bone marrow and organ function.

Exclusion Criteria

  • Have a different type of lung cancer, such as squamous or small cell lung cancer.
  • Have lung cancer that can be treated with local therapy alone.
  • Have had another cancer within the last 3 years, unless it was treated and is not active.
  • Have untreated or unstable brain or spinal cord tumors.
  • Have significant eye disease affecting the cornea.
  • Have active hepatitis B or C infection.
  • Have uncontrolled HIV infection.
  • Have an uncontrolled infection requiring IV treatment.
  • Have a history of lung disease that required steroids or have current lung disease that cannot be ruled out.
  • Have severe lung function issues.

Locations

FACILITYZIPCITYSTATE
Research Site85224ChandlerArizona
Research Site85234GilbertArizona
Research Site85338GoodyearArizona
Research Site91010DuarteCalifornia
Research Site92618IrvineCalifornia
Research Site92093La JollaCalifornia
Research Site92350Loma LindaCalifornia
Research Site90095Los AngelesCalifornia
Research Site92123San DiegoCalifornia
Research Site81501Grand JunctionColorado

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